FDA Device recall Z-0405-2014
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medi…
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medi… by Synthes Usa Hq, citing complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0405-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-08 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
Product
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
Reason
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
Identifiers
| code_info | all lots of part no. 03.802.039 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0405-2014%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.