Zimmer Universal Locking System 3 — Class II medical device recall Z-0654-2016
Terminated recall by Zimmer Biomet, Inc., reported 2016-01-20, distributed in AL, KY, ME, MN, MS, NM, NY, OH. The product on the package label did not match what was inside the package. The label was for part number 00-4
| Recall number | Z-0654-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-12-09 |
| Classified | 2016-01-14 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-11-08 |
| Distributed | AL, KY, ME, MN, MS, NM, NY, OH |
| Countries outside the US | CZ, FR, GB, IT, KR, PL, SG, SK, SV, TW, UY, ZA |
| Quantity | 52 |
| Reason classes | labeling |
| Lot numbers | 3.5MMULS, 62968956, 62968974 |
| Model numbers | 00-4936-008-07, 00-4936-011-13 |
Product
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
Reason for recall
The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.
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-0654-2016. 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.