DePuy Spine, Inc. Recalls
Showing 1-15 of 15 recalls
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
On 4/8/19, the firm distributed Medical Device Recall letters to its customers. The letter recommended that surgeons use alternative implants. In addition, customers were asked to immediately case use of the affected devices and to return all affected implants on hand. In addition, customers were asked to complete and return the business reply form. Customers were asked to notify surgeon users and others in the facility who need to be informed of the recall. If any affected product was forwarded to another facility, please immediately contact that facility to communicate the field action. For product-related questions, please contact your local DePuy Synthes Spine Sales Consultant. For questions about device recall information provided, please contact Stephanie Koenig, Recall Associate, at 574 371-4584 (M-F; 8 a.m. 5 p.m. EST).
EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L
Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
DePuy Synthes Spine issued Urgent Medical Device Recall Letter dated 5/18/21 to hospitals, sales consultants and sales managers. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject products and quarantine the subject products. DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your DePuy Synthes Spine Sales Consultant to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (See page 3 of this communication) to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this notification. Please include FA 2113300: 2022 EIT Cage in the e-mail subject line. IMPORTANT: Please complete the attached Business Response Form even if you do not have any units of the subject product on hand. 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). 5. If any of the subject product has been forwarded to another facility, contact that facility, and provide them with a copy of this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your record. Contact your DePuy Synthes Spine Sales Consultant. For Medical Information Requests, please visit our website: https://www.jnjmedicaldevices.com/mir
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesio
Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. The notification described the product, problem and actions to be taken. Notifications were sent to consignees with the following instructions: 1. Immediately identify and quarantine all unused products listed below in a manner that ensures the affected products will not be used. 2. Review, complete, sign and return the attached Business Reply Form to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 business days of receipt of this notification. 3. Return any affected product within 30 business days. A credit note will be issued for the returned items. 4. Forward this notice to anyone in your facility that needs to be informed. 5. If any impacted products have been forwarded to another facility, contact that facility and provide them with this letter. 6. Maintain awareness of this notice until all products listed below have been returned to DePuy Spine. 7. Keep a copy of this notice. If you have questions about this Field Safety Notification, please contact your DePuy Synthes Spine Sales Consultant or the Recall Coordinator via telephone: 1-508-828-6609 or via email: DPYUS-SpineFieldActions@its.jnj.com).
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Device does not mate as intended.
Consignees were notified of the recall via letter sent by overnight shipment for delivery on April 23, 2015. The letter instructs distributors and customers to review their inventory and return any products with the listed lot number.
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
The firm, DePuy Synthes Spine, sent an "URGENT! VOLUNTARY PRODUCT CORRECTION NOTIFICATION" letter dated 10/12/2016 to its Customers. Sales consultants supporting these customers received an email notification with required reply forms. The letter described the product, problem and actions to be taken. A DePuy Synthes Spine Sales consultant has been notified and will be reviewing inventory to ensure correct screw placement within your set. The customers were instructed to review, complete, sign and return the attached business reply form to DePuy Synthes Spine via email to: DPYUS-SpineFieldActions@its.jnj.com within 5 business days of receipt of this notification; forward the notice to anyone in your facility that needs to be informed; if devices have been forwarded to another facility, contact that facility and provide them with notice, and keep a copy of the notice. Questions about this recall, please contact Recall Coordinator, DePuy Synthes Spine (via telephone: 508.828.3647 or via email: DPYUS- SpineFieldActions@its.jnj.com).
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length
DePuy sent an Urgent Voluntary Product Recall Notification dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to do the following: 1. Review inventory located within your facility and quarantine any products listed in this recall notice. Please contact your DePuy Synthes Spine* Sales Consultant to return any inventory located within your facility. 2. Review, complete, sign and return the attached business reply form to in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any product listed below has been forwarded to another facility, contact that facility and provide them with this letter. 5. Keep a copy of this notice. For further questions please call (508) 828-3774
DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100
Sterility of device is compromised due to loss of package integrity
DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries.
DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
Tip of Driver may break during use
DePuy Spine notified direct accounts by visit and distributors by letter titled "Urgent - Voluntary Product Recall Notification". Accounts are requested to return the notification fax form and all affected product. For further questions, contact Depuy Spine at 1-800-227-6633.
PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
DePuy Synthes sent an Urgent Voluntary Product Recall Notification letter dated July 30, 2013, to all affected consignees via Fed Ex overnight delivery. Consignees were informed that DePuy Spine, Inc. is voluntarily recalling all lots of the PIPELINE LS ACCESS SYSTEM Dilators (1 st, 2nd, 3rd, and 4th) and Holding Clip. They were asked to review inventory located at their facility and quarantine any products listed in this recall notice. Consignees were instructed to contact their local DePuy Synthes Spine Sales Consultant to return any inventory located within their facility. Consignees with questions were instructed to call 508-828-3583.
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
DePut Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated April 15, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the con signee. Consignees were instructed to review their inventory and quarantine for return any products listed in the recall notice., complete the enclosed Business Reply Form, indicating level of inventory of the affected product and return the form to Depuy via fax to 888-943-4897or email to DePuy7862@stericycle.com and to return the product with the enclosed UPS label to Stericycle. For questions regarding this recall call 508-977-6606.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
DePuy Synthes Spine issued notification letter dated 1/11/13 issued via UPS Next Day Air Saver on 17 January 2013. Accounts requested to review inventory, quarantine any products listed in this recall notice and to complete and return the enclosed Business Reply Form. Contact the firm at 508-977-6606 for questions relating to this notice.
DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.
DePuy Spine issued an Urgent - Voluntary Product Recall Notification dated July 24, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue the use of the affected product and to remove the EXPEDIUM Offset Torque Wrenches from service and return to DePuy Synthes Spine until direction can be provided by DePuy Synthes Spine regarding a replacement torque limiting device. For questions regarding this recall call 508-828-3769.
DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
Confidence Diamond Tip Introducer Needle 11G x 6-Inch Product Code: 2839-03-611 The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed
Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle
The firm, DePuy Spine, sent an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" letter dated March 22, 2011 to its consignees/customers ( hospital sites and domestic sales distributors). A product reconciliation form was provided to assist in the retrieval of affected product. The letter described the product, problem and actions to be taken. The customers were instructed to return any needles that they may have to their local Distributor for DePuy Spine products and complete and return the Product Reconciliation Form via fax to 508-828-3762; call Customer Service at 877-379-4871 to receive a return goods authorization number and/or mail the form with the return product to DePuy Spine Inc., 50 Scotland Boulevard, Bridgewater, MA 02324, Attn: CONFIDENCE NEEDLE RECALL COORDINATOR, RGA #. If you have any questions or concerns with regard to this notice, please contact the DePuy Spine Regulatory Compliance Department at 508-828-2790.
Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile Product Code: 2883-90-000 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.
The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy
Depuy Spine issued an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" via e-mail on October 2, 2010 to customers. The notification describes the product, problem and action to be taken by customers. The customers were instructed to please distribute this information to appropriate personnel at their facility and return any caddies that they may have to their local distributor for DePuy Spine products. Depuy will return devices to customer promptly (within two business days), after reworking the devices by removing the scale altogether. Once the product is fully corrected, Depuy will provide the customers with a new and updated unit with the corrected scale markings. If you should have any questions or concerns regarding this action, please contact DePuy Spine Customers Service at 800-227-6633.