Bone Screw — Class II medical device recall Z-0824-2015
Terminated recall by Zimmer Manufacturing B.V., reported 2014-12-24, distributed nationwide. Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified
| Recall number | Z-0824-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Manufacturing B.V., N/A |
| Recall initiated | 2014-11-21 |
| Classified | 2014-12-17 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HU, IE, IT, JP, KR, MY, NL, NO, PL, PT, RS, RU, SA, SE, SG, SK, TR, TW, ZA |
| Quantity | 6,377 |
| Reason classes | device malfunction |
| Lot numbers | 00-6250-065-25, 00-6250-065-35, 62748089, 62754329, 62784617, 62784618, 62784619, 62784621, 62784622, 62793494, 62793495, 62793501, 62793502, 62793503, 62813612, 62813613, 62818701, 62818702, 62818703, 62818707, 62818709, 62818710, 62825611, 62836984 |
| Model numbers | 00-6250-065-25, 00-6250-065-35, 62748089, 62754329, 62784617, 62784618, 62784619, 62784621, 62784622, 62793494, 62793495, 62793501, 62793502, 62793503, 62813612, 62813613, 62818701, 62818702, 62818703, 62818707, 62818709, 62818710, 62825611, 62836984 |
Product
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Reason for recall
Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .
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-0824-2015. 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.