PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 14, 2015 Initiated: August 11, 2015 #Z-0027-2016

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Zimmer, Inc.
Units Affected
18 units
Distribution
Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.
Location
Warsaw, IN

Frequently Asked Questions

What product 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.. Recalled by Zimmer, Inc.. Units affected: 18 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2015. Severity: Moderate. Recall number: Z-0027-2016.

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