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

Recall Z-0027-2016 — Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devi

U.S. FDA — Device Enforcement · United States · 2015-08-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0027-2016
Date of alert
2015-08-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
56555128
Reported risk: It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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