Flex Arm Product Usage: The Synthes Flex Arm is a component of the… — Class II medical device recall Z-1511-2018
Terminated recall by Synthes, Inc., reported 2018-05-02, distributed nationwide. Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insig
| Recall number | Z-1511-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2018-03-05 |
| Classified | 2018-04-24 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2019-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, JP |
| Quantity | 84 |
| Lot numbers | 9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, H430230 |
Product
Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.
Reason for recall
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
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-1511-2018. 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.