Synthes Large External Fixation — Class II medical device recall Z-1816-2013
Ongoing recall by Synthes USA HQ, Inc., reported 2013-08-07, distributed in CA, MN, NC, TN. It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Cl
| Recall number | Z-1816-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2012-10-12 |
| Classified | 2013-07-29 |
| Reported by FDA | 2013-08-07 |
| Distributed | CA, MN, NC, TN |
| Quantity | 8 |
| Lot numbers | 6800599 |
| Model numbers | 390.007 |
Product
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Reason for recall
It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.
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-1816-2013. 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.