Device product
MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
Z-1046-2023
Product summary
- Event
- Event 91491
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 420 units
- Official record key
device-enforcement:Z-1046-2023
Official wording
Reason: 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.
Code information: GTIN 10193489120707, Lot Number 810304
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.