Recall Z-1511-2018 ยท LXH Orthopedic Manual Surgical Instrument
Synthes, Inc.
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.
| Date | Mar 5, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 84 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Switzerland and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.