FDA Device recall Z-0014-2014
Synthes Midfoot Fusion Bolt 6.5 mm
- FDA Device
- Class II
- terminated
- Published 2013-10-23
On 2013-10-23 the FDA classified a Class II recall of Synthes Midfoot Fusion Bolt 6.5 mm by Synthes Usa Hq, citing A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0014-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-08 |
| Published | 2013-10-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
Product
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Reason
A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
Identifiers
| code_info | Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547. |
|---|
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-0014-2014%22
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