Z-1047-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2023
- Initiation Date
- December 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units
Product Description
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
Reason for Recall
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN 10888277699113, Lot Number ?