Device product
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Z-0548-2022
Product summary
- Event
- Event 89382
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units (US)
- Official record key
device-enforcement:Z-0548-2022
Official wording
Reason: The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Code information: UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
Distribution pattern: US Nationwide distribution in the states of CA and OH.
Derived failure modes
-
Potency or specification failure
out of specification