Mako Surgical Corporation Recalls
Showing 1-20 of 25 recalls
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
On July 09, 2020, Stryker's issued urgent medical device recall. The following actions were instructed in the recall notification. 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3.Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4.Hospitals/Branches/Agencies: Complete and sign the Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-528-4543 or email to strykerorth8465@stericycle.com. 5.Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 6.Branches/Agencies Only: Please forward the Urgent Medical Device Recall to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2390692
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
On about 07/24/2018, Stryker sent letters to all their consignees via URGENT MEDICAL DEVICE REMOVAL letter. Instructions for risk mitigation included to perform a visual inspection the discs during pre-surgery setup as the defect can be recognized due to apparent discoloration and in the event that a Vizadisc is damaged, risk may be mitigated by testing the Vizadiscs by attaching them to the probes and arrays during pre-surgery setup, as per Stryker's recommendations in "Surgical Technique Guide." This provides an opportunity for the user to show each instrument to the camera after assembly to confirm that all discs are detectable. Additional instructions included to inform all individuals of the recall within the organization, complete and return the enclosed Recall Notification Business Reply Form, and arrange for to return all affected devices to Stryker in Mahwah, NJ. On about 11/27/2018, Stryker initiated an expansion of the recall and notified customers via "UPDATE URGENT MEDICAL DEVICE REMOVAL" letter. Instructions are the same as in the original notification letter.
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
Stryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 8/8/2022 on the same date notifying their customers of a correction for the Mako System's USB Converter, Polaris Spectra Camera. The letter provided the issue, potential hazard, potential harm, risk mitigation, and actions needed. The actions included informing users of the medical device correction and forwarding the letter to all individuals who need to be aware within their organization. Complete and sign the enclosed Business Reply Form and email to SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com within 5 days. The customer was informed Stryker will replace non-conforming USB Converter, Polaris Cameras, within the scope of the notification with qualified parts unaffected by the nonconformance. If you have any questions, please email:bradley.curtis@stryker.com.
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
The bearings of the saw attachments were ungreased.
On April 25, 2019, URGENT MEDICAL DEVICE RECALL letters under Stryker's letterhead were sent to their US consignees advising them of the issue, potential harm. This letter instructed their consignees to inform users of this device of the recall, requested that they complete the enclosed URGENT MEDICAL DEVICE RECALL BUSNESS REPLY FORM, and return all recalled product to Stryker. Actions to be taken by the Customer/ User: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-877-496-5040 or email to Stryker10077@stericycle.com 3. Hospitals/Branches/Agencies: Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07431 Ref. PFA 1958828
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee pr
Out of tolerance.
Stryker sent an Urgent Medical Device Removal letter dated May 14, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to sign the enclosed Recall Notification Business Reply Form and fax a copy to 1-855-741-4992 or email to strykerortho7035@stericycle.com.
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Incorrect product and/or label. Sizing is labeled incorrectly.
An URGENT MEDICAL DEVICE RECALL was sent on December 05, 2017 Product Field Action #: 1658081 Description: MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7 Item No.: 180612; Lot Number: 26080317-01180617; and Lot Number: 26150217-01 Dear Customer, Stryker has initiated an urgent, voluntary, lot-specific recall for the MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLA TE-RM/LL-SZ 7 referenced above. The intent of this letter is to inform you of the product recall that was initiated on December 01, 2017 by Stryker, and to list known hazards potentially associated with the use of the above referenced products and list the risk mitigation factors. Stryker has discovered that the packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. Two reports were received with the product/label discrepancy. In one report, the labeling of the implant box outer label stated Size 2 RM/LL, and the labeling of the implant sticker (Patient label) located inside the outer box stated Size 7 RM/LL. The correct implant Size 2RM/LL was inside the box. The patient label was incorrect in this report. The second report described that a size 2 implant was in a box labeled as a size 7 implant. Potential Hazards Technical and medical assessments are currently underway to determine any potential hazards associated with the use of the product. Additional communication will be forwarded upon completion of the internal investigation on this issue. Risk Mitigation The difference in Size 2 RM/LL implant and Size 7 RM/LL implant is easily identified by the end user and would not likely be implanted as the discrepancy would be obvious. Actions Needed 1. Please inform users of this Urgent Product Recall and forward this notice to all individuals who need to be aware within your organization 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Recall Notification Business Reply Form and
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.
Communication-connection error.
A customer Notification letters and Product Correction Acknowledgement Forms will be sent to affected customers via UPS Day Air return receipt. Customers where informed that the affected products will be replaced.
Restoris MCK Onlay Insert Extractor.
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Customers were initially notified on approximately 01/19/2018, and again notified when the recall was expanded on 04/25/2018. Instructions included to inform all applicable individuals within the organization that need to be notified, complete and return the Recall Notification Business Reply Form, and make arrangements for return all affected products on hand. On about 12/12/2018, Stryker expanded the scope of the recall to include two additional lot codes and notified customers via "URGENT MEDICAL DEVICE REMOVAL" letter. Instructions were the same as the original recall notification.
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Customers were sent notices titled "Urgent Medical Device Correction Notification" on 06/12/2017 via UPS Next Day Mail. The firm notifies consignees of the reason for recall and instructs that users of the recalled product be provided the recall notice. Users may continue to use their MAKO system; and, Stryker/MAKO Service personnel will contact users o schedule time to inspect and replace the card cage, if necessary. Also, users are instructed to return the completed Business Reply Form within 5 business days. The completed form can be sent to strykerortho7391@stericycle.com or faxed to 855-544-4807. Any questions can be directed to Clayton Odor at 954-628-0502.
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Software discrepancy of not showing all the EE constants, when the screen is filled.
There will be no communication to the customer. Notification shall only go to the MAKO Product Specialist and Branch Managers as this action is not a customer facing issue. These letters and acknowledge forms were sent via Federal Express Two Days Air with return receipt.
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Letter from Stryker dated 1/28/2017 was sent via USP Next Day Air with return receipt to all their customers. With the following actions; Inform users of this medical device correction and forwar this notice to all those individuals who need to be aware within your organization and return the attached Business Replay Form within 5 business days, to Fax 844-782-5561 or via e-mail to stykerortho4253@stericycle.com
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
Failure of the Offset Cup Reamer Handle not engaging its mating components.
Customers were sent a recall notificaiton letter, dated 10/17/2016, addressing the reason for recall and the appropriate actions that should be taken by customers. Consignees are instructed to return any recalled product on hand to Stryker C/O Stericycle, 2670 Executive Dr. Suite A, Indianapolis, IN 46241, Attn RA 2016-083, RA 2016-119 - Event 8811. Consignees are also instructed to inform their users of this recall and forward the notice to affected individuals. A Business Reply Form was provided and is to be completed within 5 business days of receipt by consignees. Completed business reply forms are to be faxed to 855-620-5693 or emailed to strykerortho8811@stericycle.com.
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
The firm, Stryker Orthopaedics, sent an "Urgent Product Recall" letter dated 1/15/2016 to all their consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to inspect the device packaging as the damage to the sterile barrier may be notice prior to the procedure; do not use the device if the seal or package is breached and complete and return the attached Product Recall Acknowledgment Form within 5 days by e-mail StrykerOrtho5317@Stericycle.com or fax at: 888-480-2853. Return all affected products available at your location to: Stryker c/o Stericycle, 2670 Executive Dr., Suite A, Indianapolis, IN 46241, Attn. RA2015-047-Event 5317. If you have any questions, feel free to contact Sr. Director QA at 954-628-0502.
Robotic Arm Interactive Orthopedic System (RIO)
Revision of the field manual
As per our conversation with firm representative on March 23, 2016, they stated "no notification was sent to the customers", and referred to Ref: Part 806 File number: RA 2015-017 where it states "Stryker Orthopaedics has completed a retrospective review of other revisions to the field service manual, and we have confirmed there are no other similar events for which Part 806 reports should have been submitted". For further questions, please call (866) 647-6256. Internal actions taken only.
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Potential disassociation of the orientation pin.
On March 4, 2016 Stryker Orthopaedics initiated a voluntary product recall of the RESTORIS PST RIO Offset Shell Impactor informing the customer in an Urgent Product Recall to do the following: 1. Inspect all metal instruments for any damage or difficulty disassembling/assembling instruments 2. Return all affected products at their location to Stryker C/O Stericycle, 2670 Executive Dr. Suite A, Indianapolis, IN, 46241, Attn of Event 8763, Clayton Odor. 3. Complete and sign the Business Reply Form and send it back via e-mail or fax within five business days. Contact 866-241-0741 or via e-mail strykerortho8763@stericycle.com
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
As of July 16, 2015, Mako communicated by mail the nature of the recall to their Product Specialists and the OR Administrators describing the specifics regarding the issue for correction.
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
On January 22, 2015 the firm sent an IMPORTANT MEDICAL DEVICE CORRECTION asking consignees to complete the attached acknowledgement form and return them by email, fax or mail. The notice also noted the RIO system can continue to be used. The likelihood of occurrence is rare (.035% of cases) and the event is readily detectable and can be resolved. Should you have any questions regarding this Important Medical Device Recall Notice, to contact us at (954) 628-1721.
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
MAKO Surgical Corporation sent an Important Medical Device Recall Notice dated October 7, 2014, to all affected customers. The letter identified the product, the problem, and hte action to be taken by the customer. Customers were instructed to review their inventory for the affected product and return affected inventory to MAKO, Ft. Lauderdale. Customers were instructed to provide the Recall Notification to all field personnel to enhance awareness of the event. Customers were instructed to complete the attached acknowledgement form indicating receipt of the notice. Customers were asked to sign and return the form to MAKO Surgical by the following methods: Email: SYKMakoFLQualitySystems@stryker.com Fax to (954) 423-1547 Mail using enclosed self addressed stamped envelope tp: MAKO Surgical Corporation 2555 Davie Road Ft. Lauderdale, FL 33317 so that the field personnel 1) Recall Notification communicated by MAKO Customer Service on 10/7/2014 to affected MAKO field personnel, directing them to review their affected customer's site inventory and return affected inventory to MAKO Ft. Lauderdale. Field personnel will sign an Acknowledgment form and return it to MAKO Quality. 2) Recall Notification communicated by MAKO Quality department to the affected sites OR Administrators notifying them of the recall event and providing an Acknowledgment form for return to MAKO Quality to document their awareness. 3) The Recall Notification provided to all MAKO field personnel to enhance awareness of the event so that the field personnel can provide answers to questions their site personnel may have regarding the event. If you have any questions contact us at (954) 628-1721.
MAKOplasty Hip Array Kit Laminate 150230
Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.
On 12/09/2015, Product Field Action Letters and Product Accountability forms were sent to Branch/Agencies via overnight courier with a return receipt; Hospital Risk Management were sent Notification letters and a Product Recall Acknowledgement form with return receipt on 12/9;/2015.
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components wer
The product may be mislabeled and could result in the incorrect implant being used.
MAKO Surgical Corporation sent an Important Medical Device Recall Notice letter dated January 9, 2014 to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them the return of the product that will be replaced at no charge. Customers were asked to sign and return the Acknowledgement form to MAKO Surgical using one of the following methods: Email, Fax or Mail. For questions, customers were instructed to call (954) 628-1721. For questions regarding this recall call 954-628-0607.