Zimmer Universal Locking System — Class II medical device recall Z-0027-2016
Terminated recall by Zimmer, Inc., reported 2015-10-14, distributed in AL, CA, KS, NC, TX, UT. It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal
| Recall number | Z-0027-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-08-11 |
| Classified | 2015-10-06 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-03-15 |
| Distributed | AL, CA, KS, NC, TX, UT |
| Countries outside the US | SG |
| Quantity | 18 units |
| Lot numbers | 56555128 |
| Model numbers | 00-4836-080-00 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0027-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.