Inserter for Titanium Elastic Nails — Class II medical device recall Z-0125-2016
Terminated recall by Synthes (USA) Products LLC, reported 2015-10-21, distributed nationwide. potential for mechanical failures such as breakage.
| Recall number | Z-0125-2016 |
|---|---|
| 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 | 2015-09-03 |
| Classified | 2015-10-15 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2016-10-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 1,550 |
| Reason classes | device malfunction |
| Lot numbers | 1095607, 1121876, 1641700, 1806500, 1811056, 1811059, 1813900, 1904339, 3005674, 3005675, 3009312, 3020674, 3025607, 3051190, 3054608, 3065013, 3069566, 3084637, 3098634, 3121438, 3232931, 3242304, 3262712, 3301017, 3325276, 3382583, 3410330, 3430483, 3493588, 3504996, 3524633, 3619119, 3626055, 3659645, 3706611, 3797835, 4321659, 4340451, 4389269, 4466686 and 116 more |
| Model numbers | 359.219 |
Product
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Reason for recall
potential for mechanical failures such as breakage.
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-0125-2016. 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.