OrthoPediatrics Corp Recalls
Showing 1-20 of 20 recalls
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
OrthoPediatrics Corp. provided Urgent Medical Device recall Letter to Distributors on 6/29/22. Letter states reason for recall, health risk and action to take: The affected product must be returned to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. Distributors should retrieve affected product that may be with customers. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response acknowledgement form confirming your understanding of these instructions. Any questions regarding this recall can be directed to Joel Batts, Senior VP of Science & Technology, at OrthoPediatrics at jbatts@orthopediatrics.com or 574-367-5396.
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
OrthoPediatrics Corporation issued Urgent Medical Device Correction notices dated June 5, 2020 to customers via email. Customers are advised to return affected product to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response form confirming your understanding of these instructions. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orthopediatrics.com or 574-267-0897.
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
OrthoPediatrics, Inc. notified Distributors by letter via email on 8/19/19 , stating reason for recall, health risk and action to take: Distributors have been instructed to review their inventory and the inventory at their clinical sites to recover the product. Questions contact: Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orthopediatrics.com or 574-267-0897.
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
Orthopedics issued Field Action Notice distributed via email on July 6, 2002 stating reason for recall , heath risk and action to take: Distributors are required, to perform sub-recall. The affected product must be returned to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. Distributors should retrieve affected product that may be with customers. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response form confirming your understanding of these instructions. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orthopediatrics.com or 574-267-0897
Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
On August 19, 2019, the firm notified customers of the issue via emailed notice titled Urgent Medical Device Recall. Customers were informed of the issue of binding between the attachment bolt and the intramedullary nail. The firm asked customers to return all attachment bolts in the field. The issue does not impact intramedullary nails that have been implanted. No additional corrective actions need to be taken for product already implanted. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orthopediatrics.com or 574-267-0897.
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
On August 4, 2017 an urgent medical device recall letter, titled "Response 5.5/6.0 Spine System - 7.0mm x 40mm UNIAXIAL PEDICLE SCREW" was issued to customers with instruction to quarantine affected product, which will be returned to the recalling firm for destruction. Questions or concerns can be directed to logistics@orthopediatrics.com or calling (574) 268-3692
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
Over-tensioning of the band resulting in damage to the band causing it to rupture
The firm, OrthoPediatrics Corp., contacted each distributor/consignee via phone on 4/24/2017, regarding the recall. The phone call informed Consignees of issue and actions to be taken. The consignees were instructed to return of devices in their control were issued; cease further distribution of the product and quarantine it. The firm state that product will be distributed after Rework to new revision. If you have any questions, contact V.P. Regulatory Affairs, at (574) 268-6379 or email: mfox@orthopediatrics.com.
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Labeled as a 48mm Cortical Screw but measuring at 50mm
OrthoPediatrics sent an URGENT MEDICAL DEVICE RECALL notification on November 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. . It is important that you carefully follow these recall instructions: " Please immediately take possession of any of these screws your customer may have or that you have, and quarantine them. Contact logistics@orthopediatrics.com to receive a Return Authorization Number. It is very important that we contain these devices rapidly and maintain them in quarantine. Replacement devices can be ordered from Customer Service. " The FedEx package you receive will contain a pre-addressed FedEx return label for the return of the recalled screw(s). " Included in this FedEx package is a Mandatory Reply Form for you to indicate the total number of affected screw(s) in your sets. We will be providing any additional follow up instructions as needed. If you have any questions call (574) 267-0865. For further questions regarding this recall , please call (574) 268-6379
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
Orthopediatrics initiated the recall of 3.5mm Bowed Locking Compression Femur Plates by distributing e-mails on 0July 27, 2016, followed by telephone calls to all customers on July 28, 2016. All distributors and direct representatives were sent an e-mail to provide them with a written notification of the voluntary recall and instruct them to quarantine all identified devices from the affected lot numbers immediately. Customers were instructed to quarantine recalled product and response via a hard copy Reply Form that was included in a hard copy of the Recall Notice. Each sales representative was also asked to contact Orthopediatrics Logistics Department to receive a Return Authorization Number for returning recalled product. in order to track their affected plates. If customers have any questions about this recall, they were instructed to reach out to the firm via phone (office: 574-267-0865) or email (acargill@orthopediatrics.com).
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i
Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
The firm, OrthoPediatrics Corp., sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/13/2015 to affected customers via email. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and actions to be taken. The customers were instructed to take immediate possession of all the identified devices; quarantine them and immediately return them to OrthoPediatrics, and complete and return the Mandatory Reply Form via fax to (574) 269-3692 or email: MF0x@OrthoPediatrics.com. If you have any questions, please contact VP-Regulatory Affairs (574) 268-6379 or email: mfox@orthopediatrics.com.
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2510, 3.5mm Non Locking Cortical Screw, Lot # 150192-J, initially by contacting customers via telephone, and then by e-mailing notification letters on 7/28/2015. Customers returned the 5 mislabled screws, which were repacked with correct labeling. All recall activities were complete as of 8/14/2015.
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
OrthoPediatrics sent a Notification letter dated July 25, 2014 to all affected customers. The letter Identified the affected product, problem and actions to be taken. The letter informed customers to take immediate possession of all affected product within their control and at any of their health care facilities and immediately return the recalled device(s) to OrthoPediatrics Corp. This notice and the attached Reply Form should be forwarded if the affected product was further distributed. .
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.
Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
November 7, 2013 all consignees were notified of the Urgent Device recall via telephone calls and E-mail messages describing the product and reason for the recall,. The notice included directions to identify and quarantine the recalled devices returning product to OrthoPediatrics with completed return form to OrthoPediatrics via mail, email or courier service, or by photographing with a smart phone and emailing to logistics@orthopediatrics.com or by answering the recall specific questionsin an email to mfox@orthopediatrics.com
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.
Orthopediatrics Corporation has requested sales representatives and distributors who have been identified via shipping records as having the possibility of having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on January 8, 2014. The decision to Recall these devices was made and a formal written Recall Notice sent to the consignees via email on January 13, 2014. Notification will not be sent to hospitals at this time provided that all devices are retrieved or accounted for within 60 days of the initiation of recall. Hospitals will be notified on an as needed basis if OrthoPediatrics determines that all recalled devices have not been recovered or accounted for, and that contacting the hospitals involved will expedite the recall efforts. All discrepant devices subject to this voluntary Recall are planned to be returned from distribution to OrthoPediatrics Corp. in Warsaw, Indiana and maintained in quarantine. All remaining unshipped devices from these lots have been placed in quarantine at OrthoPediatrics Corp. All quarantined devices at OrthoPediatrics will be inspected and repackaged to correct the mislabeling per normal documented procedures. Objective evidence will be maintained of the rework of the devices. For questions regarding this recall call 574-268-6379.
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with
The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
OrthoPediatrics sent an Urgent Medical Device Recall letter dated September 26, 2013, to all affected customers.The letter identified the product the problem and the actions needed to be taken by the customer The sales representatives and distributors who have been identified via shipping records as having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on 18-September-2013. If you or any of your customers have any of these devices in the original packaging please take possession of them and quarantine them in preparation for returning them to OrthoPedlatrics. They are misbranded. If the Screw has already been removed from the original packaging and the original packaging has been discarded and the Screw placed in a sterilization tray, it need not be returned. For further questions please call ( 574) 268-6379.
90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures an
Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
OrthoPediatrics sent an Urgent Voluntary Recall notifiation via telephone and email to all affected consignees. The letter instructed consignees to take possession of any affected devices and quarantine immediately. A Mandatory Reply Form is included with the notification letter to be completed and returned. Please contact Greg Teghtmeyer if you have any questions (574-268-6379).
4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc system. The PediLoc Extension Osteotomy Plate consists of 3.5mm and 4.5mm p
Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
OrthoPediatrics sent an "URGENT RECALL" e-mail of the Trochar Scalpel Instrument to all affected customers. The e-mail identifies the product, problem, and actions to be taken by the customers. The e-mail states that the instrument has been manufactured incorrectly and will not work (function as intended). The threads in the instrument are faulty and the guide tubes will not thread in correctly. Customers will receive follow up information.
Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatri
A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
OrthoPediatrics Corp sent an Urgent Recall e-mail dated September 14, 2012, to all affected customers. The e-mail identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all identified devices from the affected lot numbers immediately. Customers were also asked to complete the Mandatory Reply Form. Customers with questions should call 574-268-6379.
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
On 7/24/13, OrthoPediatrics notified their consignees of this URGENT MEDICAL DEVICE RECALL via phone call. A follow-up email message was then sent with the recall notification, and then a hard copy of the notice was sent via certified letter. The notification addresses the affected product, recall issue, reply form instructions, and directs consignees to return affected product to OrthoPediatrics via a Fed-Ex return prepaid pouch. The firm directs consignees to forward the notification and reply form if the product was further distributed.
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
On 15-June-2012, a follow-up, URGENT Recall of MIS-BRANDED PediLoc Locking Plate e-mail was sent to all Distributors and direct representatives to provide them with a written notification of the voluntary recall. The e-mail identified the affected product and the reason for the recall. It also instructed them to quarantine all identified devices from the affected lot number immediately. A certified Voluntary Recall notice was also sent as a follow up along with a return prepaid pouch for the return of the recalled device(s) and Mandatory Reply Form.