Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10

FDA Device Recall #Z-2362-2018 — Class II — May 30, 2018

Recall Summary

Recall Number Z-2362-2018
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 294

Product Description

Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10

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

62107667 62410983 62410984 62445410 62449677 62450635 62469393 62478848 62478852 62478855 62503181 62547038 62554172 62559999 62560152 62577929 62630007 62636746 62652981 62659334 62667678 62753395 62770876 62777941 62791158 62806022 62897465

Other Recalls from Zimmer Biomet, Inc.

Recall # Classification Product Date
Z-0696-2021 Class II Spinal Rod Cutter, Item number 00392500200. The... Nov 20, 2020
Z-0570-2021 Class II Polaris 5.5 Spinal System and Polaris 5.5/Cyphe... Nov 17, 2020
Z-0372-2021 Class II ZCA All Poly Acetabular Cup Longevity Crosslink... Sep 24, 2020
Z-0345-2021 Class II ZCA All Poly Acetabular Cup Longevity Crosslink... Sep 24, 2020
Z-0347-2021 Class II ZCA All Poly Acetabular Cup Longevity Crosslink... Sep 24, 2020

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.