Recall Z-0548-2022
Smith & Nephew, Inc. · initiated January 4, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Codes / lots: UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
Reason for recall
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
FDA-determined cause: Process control
Action taken
The firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product.
Details
- Recall number
- Z-0548-2022
- Initiated
- January 4, 2022
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 8 units (US)
- Distribution
- US Nationwide distribution in the states of CA and OH.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN