Recall Z-0027-2016— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2015-08-11, terminated 2016-03-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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.
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-11
- Terminated
- 2016-03-15
- Firm location
- Warsaw, IN, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.