Recalls / —
—#189506
Product
6.5MMX165MM CANNULATED SCREW
- FDA product code
- HWC — Screw, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K060736
- Affected lot / code info
- Model 71106365S; Lot 20GT39417
Why it was recalled
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.
Timeline
- Recall initiated
- 2021-09-20
- Terminated
- 2023-03-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #189506. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.