FDA Enforcement
Class II
Ongoing
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Recall: Z-0548-2022
·
Reported February 9, 2022
Enforcement
- Recall Number
- Z-0548-2022
- Event ID
- 89382
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Smith & Nephew, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 9, 2022
- Initiation Date
- January 4, 2022
- Classification Date
- February 1, 2022
- Address
- 1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States
Description
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Reason
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Code Info
UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
Distribution
US Nationwide distribution in the states of CA and OH.
Quantity
8 units (US)