FDA Recall
Completed
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Recall: Z-1361-2022
·
Initiated October 7, 2021
Recall
- Recall Number
- Z-1361-2022
- Event Number
- 90281
- Firm
- SCIENCE & BIO MATERIALS Zi Du Monge Lourdes France
- FEI Number
- 3004051158
- Product Code
- HWC
- Status
- Completed
- Root Cause
- Process control
- Initiated
- October 7, 2021
Description
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Reason
Mislabeled product.
Action
The firm notified its US distributor of the recall by email on 30 September 2021. The notice requested quarantine of the device and for the distributor to notify all interested parties with their organization and to any organization to which the device was transferred.
Distribution
US Nationwide distribution.
Quantity
72 units