Recall Z-1361-2022 ยท HWC Screw, Fixation, Bone
SCIENCE & BIO MATERIALS
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
| Date | Oct 7, 2021 |
| Status | Completed |
| Reason | Mislabeled product. |
| Root cause | Process control |
| 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. |
| Quantity | 72 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070507 | MODIFICATION TO: LIGAFIX INTERFERENCE SCREW Science For Biomaterials, Mar 29, 2007 |