Recall Z-0072-2022 ยท BWN Table And Attachments, Operating-Room
Innovative Orthopedic Technologies, LLC
ARCH Leg Positioning System
| Date | Sep 13, 2021 |
| Status | Terminated |
| Reason | Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. |
| Root cause | Device Design |
| Action | On 09/13/2021, the firm sent via certified mail an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customers informing them that the Leg Positioning System is being recalled due to a manufacturing defect that may make locking the flexion/extension carriage into position difficult under load. Customers are instructed to: 1. Contact the Recalling Firm to schedule repair of their device. 2. While customers are waiting for the repair of their device, lifting the boot to lighten the load will pushing the locking pin into place can alleviate the issue. 3. Complete and return the Acknowledgem |
| Quantity | 10 units |
| Distribution | U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.