I — Class II medical device recall Z-0908-2015
Terminated recall by DePuy Orthopaedics, Inc., reported 2015-01-14, distributed nationwide. Use of excessive force when impacting may lead to intra-operative femoral fracture.
| Recall number | Z-0908-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-11-12 |
| Classified | 2015-01-05 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, FR, GB, IL, IN, IT, JP, MY, RU, ZA |
| Quantity | 1,130 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10603295224389 |
| Model numbers | 9505-01-041 |
Product
I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.
Reason for recall
Use of excessive force when impacting may lead to intra-operative femoral fracture.
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-0908-2015. 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.