FDA Device recall Z-0027-2016
Zimmer Universal Locking System, Titanium 3.5mm
- FDA Device
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of Zimmer Universal Locking System, Titanium 3.5mm by Zimmer, citing 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 si….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0027-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-11 |
| Published | 2015-10-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | AL, CA, KS, NC, TX, UT |
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
Identifiers
| code_info | Item No. 00-4836-080-00; Lot 56555128 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0027-2016%22
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