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

Recall Z-1981-2013 — Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.

U.S. FDA — Device Enforcement · United States · 2013-07-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1981-2013
Date of alert
2013-07-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
25621400
Reported risk: Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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