Synthes Trauma Ex-Fix System — Class II medical device recall Z-2451-2015
Terminated recall by Synthes (USA) Products LLC, reported 2015-09-02, distributed nationwide. Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Condi
| Recall number | Z-2451-2015 |
|---|---|
| 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 | 2015-07-29 |
| Classified | 2015-08-24 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2016-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 5,306,080 |
| Reason classes | labeling |
| Model numbers | 03.301.010S, 03.301.011S, 03.301.012S, 03.301.013S, 03.304.220S, 03.304.222S, 03.304.320S, 03.304.322S, 03.311.010, 03.311.011, 03.311.012, 03.311.013, 03.311.015, 03.311.020, 03.311.022, 03.311.023, 03.311.024, 03.311.025, 03.311.031, 03.311.032, 03.311.033, 03.311.036, 03.311.037, 03.311.038, 03.311.041 and 371 more |
Product
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult fractures; )L) for use to provide treatment for long bone and pelvic fractures that require external fixation; and (DO) for fracture fixation (open and closed),pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphysical 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
Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR Conditional. One serious injury reported.
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-2451-2015. 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.