FDA Device recall Z-0219-2015
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the pr…
- FDA Device
- Class II
- terminated
- Published 2014-11-26
On 2014-11-26 the FDA classified a Class II recall of 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the pr… by Synthes, citing the 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0219-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-29 |
| Published | 2014-11-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | AK, FL, OH, OK, TX |
Product
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Reason
The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
Identifiers
| code_info | part number: 456.316S, lot number: 7782247 |
|---|
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-0219-2015%22
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