Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System… — Class II medical device recall Z-0473-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-18, distributed nationwide. A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System"
| Recall number | Z-0473-2014 |
|---|---|
| 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 | 2013-10-09 |
| Classified | 2013-12-10 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2015-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 2,912 |
| Reason classes | labeling |
Product
Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
Reason for recall
A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.
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-0473-2014. 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.