Synthes Tensioning Device The Synthes Osteogenesis System — Class II medical device recall Z-0388-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-04, distributed nationwide. All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loo
| Recall number | Z-0388-2014 |
|---|---|
| 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 | 2013-07-31 |
| Classified | 2013-11-25 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 369 |
| Lot numbers | 03.311.001, 1934765, 1934766, 1993844, 3036688, 3398576, 3776484, 5100597, 5106354, 5160872, 5160875, 5174253, 5174254, 5181000, 5181001, 5196282, 5196283, 5197081, 5241942, 5241943, 5336723, 5363637, 5396016, 5411479, 5555521 |
| Model numbers | 03.311.001 |
Product
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Reason for recall
All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.
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-0388-2014. 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.