11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right — Class II medical device recall Z-0604-2018
Terminated recall by Synthes (USA) Products LLC, reported 2018-02-21, distributed in GA, PA, TX, UT. The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
| Recall number | Z-0604-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2017-07-21 |
| Classified | 2018-02-13 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-07-10 |
| Distributed | GA, PA, TX, UT |
| Countries outside the US | CA |
| Quantity | 4 units |
| Reason classes | sterility |
| Lot numbers | H302839 |
| Expiration dates | 2026-01-31 |
Product
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Reason for recall
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
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-0604-2018. 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.