Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2371-2018 — Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00

U.S. FDA — Device Enforcement · United States · 2018-05-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2371-2018
Date of alert
2018-05-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
11016141
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.