Z-1511-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- March 5, 2018
- Termination Date
- October 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Switzerland and Japan
Code Information
Lot numbers 9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, H430230