Synthes External Fixation Systems — Class II medical device recall Z-1833-2014
Terminated recall by Synthes, Inc., reported 2014-06-25, distributed nationwide. Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes i
| Recall number | Z-1833-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-04-10 |
| Classified | 2014-06-19 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2016-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 5,114,052 |
| Reason classes | labeling |
| Model numbers | 03.301.010S, 03.301.011S, 03.301.012S, 03.301.013S, 293.35, 293.36, 293.40, 293.41, 293.42, 293.44, 293.45, 293.46, 293.47, 293.48, 293.48L, 293.48X, 293.49, 293.50, 293.51, 293.52, 293.53, 293.54, 293.58, 293.59, 293.62 and 179 more |
Product
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Reason for recall
Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
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-1833-2014. 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.