M/DN Intramedullary Fixation 4 — Class II medical device recall Z-1678-2016
Terminated recall by Zimmer Manufacturing B.V., reported 2016-05-25, distributed nationwide. A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
| Recall number | Z-1678-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Manufacturing B.V., Mercedita, PR, United States |
| Recall initiated | 2016-05-04 |
| Classified | 2016-05-16 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2017-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CN, DE, ES, FR, GB, HK, IN, IT, JP, KR, SE, SG, SV, TW |
| Quantity | 219 |
| Reason classes | sterility |
| Lot numbers | 63293672, 63295051 |
Product
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
Reason for recall
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
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-1678-2016. 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.