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Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00

FDA Device Recall #Z-2369-2018 — Class II — May 30, 2018

Recall Summary

Recall Number Z-2369-2018
Classification Class II — Moderate risk
Date Initiated May 30, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 1024

Product Description

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00

Reason for Recall

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Distribution Pattern

Products were distributed solely to Japan.

Lot / Code Information

61288759 61542760 61710043 61729725 61735130 61768446 61805951 61843648 61874222 61950885 61957017 61967640 61967642 61985977 62010557 62014550 62059104 62124960 62134980 62153554 62163677 62191383 62225911 62270944 62273474 62275220 62275874 62316364 62329143 62356225 62418056 62420829 62420831 62420832 62432973 62472159 62503173 62521423 62521424 62521425 62521426 62540539 62571382 62578409 62652963 62659314 62659315 62667476 62700958 62721036 62739979 62761717 62776407 62787314 62787315 62794382 62815408 62836783 62836785 62885067 62939020 62939021 62939023 63044942 63051893 63063344 63063345 63063346 63063348 63068961 63068965 63068967 63068969 63076579 63076580 63081284 63081286 63090043 63090044 63094542 63102029 63102030 63108843 63174078 63174079 63174081 77004214 61429027R 62066989R 62335432R 62836786R

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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