Device 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.
Z-1511-2018
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 79763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84
- Official record key
device-enforcement:Z-1511-2018
Official wording
Reason: Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
Code information: Lot numbers 9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, H430230
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Switzerland and Japan
Derived failure modes
-
Unknown
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.