Synthes Inserter for Titanium Elastic Nails — Class II medical device recall Z-1260-2015
Terminated recall by Synthes, Inc., reported 2015-03-18, distributed nationwide. The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for
| Recall number | Z-1260-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2015-02-03 |
| Classified | 2015-03-10 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2016-08-26 |
| Distributed | Nationwide (US) |
| 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
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.
Reason for recall
The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN.
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-1260-2015. 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.