Synthes Titanium Cannulated Humeral Nail Intended to aid in the… — Class II medical device recall Z-0407-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-04, distributed nationwide. The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead
| Recall number | Z-0407-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-07-30 |
| Classified | 2013-11-26 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 14 |
| Lot numbers | 04.001.218S, 04.001.444S, 04.001.620S, 04.001.622S, 04.001.636S, 04.001.638S, 04.001.640S, 04.001.642S, 04.001.644S, 7115414, 7115417, 7115509, 7115510, 7115533, 7117902, 7117916, 7117924, 7117995, 7117998, 7119089, 7119107, 7119125, 7265517, 7327816, 7379241 |
| Model numbers | 04.001.218S, 04.001.444S, 04.001.620S, 04.001.622S, 04.001.636S, 04.001.638S, 04.001.640S, 04.001.642S, 04.001.644S, 7115414, 7115417, 7115509, 7115510, 7115533, 7117902, 7117916, 7117924, 7117995, 7117998, 7119089, 7119107, 7119125, 7265517, 7327816, 7379241 |
Product
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Reason for recall
The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
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-0407-2014. 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.