FDAFDA · Food and drugs·Recall number 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 devices.
Published October 14, 2015 · Recall initiated: August 11, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.
- Lot
- Item No. 00-4836-080-00; Lot 56555128
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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