10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM — Class II medical device recall Z-0219-2015
Terminated recall by Synthes, Inc., reported 2014-11-26, distributed in AK, FL, OH, OK, TX. The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly
| Recall number | Z-0219-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-10-29 |
| Classified | 2014-11-14 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2015-12-18 |
| Distributed | AK, FL, OH, OK, TX |
| Quantity | 6 |
| Reason classes | sterility, specification failure |
| Lot numbers | 7782247 |
| Model numbers | 456.316S |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0219-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.