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.
This recall has been terminated (originally issued March 5, 2018).
- Company
- Synthes, Inc.
- Recall Initiated
- March 5, 2018
- Terminated
- October 16, 2019
- Recall Number
- Z-1511-2018
- Quantity
- 84
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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
Worldwide distribution - US Nationwide and the countries of Canada, Switzerland and Japan
Lot / Code Info
Lot numbers 9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, H430230
Root Cause
Device Design
Action Taken
The firm sent an Urgent Product Recall letter dated March 21, 2018, to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-610-719-5450 or contact your DePuy Synthes Sales Consultant.