Recall Z-0143-2022
Smith & Nephew, Inc. · initiated September 20, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
6.5MMX165MM CANNULATED SCREW
Codes / lots: Model 71106365S; Lot 20GT39417
Reason for recall
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
FDA-determined 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.
Details
- Recall number
- Z-0143-2022
- Initiated
- September 20, 2021
- Terminated
- March 24, 2023
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 5 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN