Recall Z-1361-2022
Science & Bio Materials · initiated October 7, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Codes / lots: Product code: 110004605; Lot #: 190491, Use before 01/01/2022. GTIN 03760154006767
Reason for recall
Mislabeled product.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1361-2022
- Initiated
- October 7, 2021
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 72 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Science & Bio Materials, Lourdes