Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma… — Class II medical device recall Z-1547-2013
Terminated recall by Biomet, Inc., reported 2013-06-26, distributed nationwide. Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Num
| Recall number | Z-1547-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-04-29 |
| Classified | 2013-06-14 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2015-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR, JP, NL |
| Quantity | 75 |
| Lot numbers | 757910 |
| Model numbers | 14-442021 |
Product
Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Reason for recall
Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. The connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (Part Number: 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in su
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-1547-2013. 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.