6.5MMX165MM CANNULATED SCREW
This recall has been terminated (originally issued September 20, 2021).
- Company
- Smith & Nephew Inc
- Recall Initiated
- September 20, 2021
- Terminated
- March 24, 2023
- Recall Number
- Z-0143-2022
- Quantity
- 5 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
Distribution
Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.
Lot / Code Info
Model 71106365S; Lot 20GT39417
Root Cause
Process control
Action Taken
Smith & Nephew issued a customer letter via email dated September 20, 2021. Consignees are asked to inspect inventory and locate any devices from the listed product and batch numbers enclosed with the Urgent Medical Device Recall Notice, and quarantine them immediately. Consignees must complete the enclosed response form, sign and send to FieldActions@smith-nephew.com. Response form shall be completed even if there is no impacted product on hand.