FDA Device recall Z-1547-2013
Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems
- FDA Device
- Class II
- terminated
- Published 2013-06-26
On 2013-06-26 the FDA classified a Class II recall of Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems by Biomet, citing 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 specifi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1547-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-29 |
| Published | 2013-06-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
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
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
Identifiers
| code_info | Catalog number: 14-442021 and lot number:757910 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1547-2013%22
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