Innovative Orthopedic Technologies, LLC Recall 88636
Description: ARCH Leg Positioning System
Innovative Orthopedic Technologies, LLC Recall 88636 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0072-2022 |
| Event ID | 88636 |
| Event Description | ARCH Leg Positioning System |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX. |
| Quantity | 10 units |
| Recall Reason | Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. |
| Device Classification | 20211013 |
| Device Code Info | Model: 6813010 Serial Numbers: 6813010.0066; 6813010.0067; 6813010.0069; 6813010.0070; 6813010.0071; 6813010.0072; 6813010.0073; 6813010.0074; 6813010.0075; 6813010.0076; |
| Center Classification Date | 20211007 |
| Recall Initiation Date | 20210913 |
| Recalling Firm | Innovative Orthopedic Technologies, LLC |
| Initial Notification | Letter |
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