Zimmer, Inc. recalls Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devi…

Recall date

August 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0027-2016

FDA classification

Class II

Brand / firm

Zimmer, Inc.

Sold / distributed

Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.