FDA-Device2015-10-14Class II
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 devices.
Zimmer, Inc.
Hazard
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
Sold states
Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.
Affected count
18 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
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 devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0027-2016Don't want to check this manually?
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