Drill Template and the Saw Guide for the Ulna Osteotomy System — Class II medical device recall Z-1274-2014
Terminated recall by Synthes, Inc., reported 2014-04-02, distributed nationwide. The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking o
| Recall number | Z-1274-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-01-07 |
| Classified | 2014-03-25 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2015-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 343 |
| Lot numbers | 2638601, 2638603, 2638604, 2638605, 7769386, 7772531, 7772538, 7772542, 7772543, 7772554, 7772555, 779372, 7836420, 7836422, 7836423, 7872775, 7915554, 8229040, 8400287 |
| Model numbers | 03.111.900 |
Product
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
Reason for recall
The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template.
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-1274-2014. 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.