FDA Device recall Z-2058-2013
Synthes Trauma Nail System
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of Synthes Trauma Nail System by Synthes Usa Hq, citing recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2058-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-02 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
Product
Synthes Trauma Nail System. The devices are indication for bone fixation.
Reason
Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
Identifiers
| code_info | Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897 |
|---|
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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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…
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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-2058-2013%22
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