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.
Other recalls by Synthes Usa Hq
- Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and w…
FDA Device · Class II · 2014-01-08 · Synthes Usa Hq - Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable…
FDA Device · Class II · 2013-12-18 · Synthes Usa Hq - Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal ti…
FDA Device · Class II · 2013-12-18 · Synthes Usa Hq - Synthes Soft Tissue Retractor Small Extendible
FDA Device · Class II · 2013-12-11 · Synthes Usa Hq - Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur
FDA Device · Class II · 2013-12-11 · Synthes Usa Hq
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0014-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.