Trilogy self-tapping bone screw Bone screw 4 — Class II medical device recall Z-1684-2016
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-1684-2016 |
|---|---|
| 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 | 3,893 |
| Reason classes | sterility |
| Lot numbers | 63187350, 63204283, 63209528, 63225662, 63257719, 63259476, 63272712, 63284570, 63284572, 63284573, 63296123, 63301504 |
Product
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw 6.5x25 selftap 00625006525 Bone screw 6.5x30 selftap 00625006530
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-1684-2016. 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.