Recalls / —
—#153151
Product
Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
- FDA product code
- HAB — Saw, Powered, And Accessories
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Batch Numbers: 50439354 50393992 50252777 50208023 50171402 50138054 50103142 50066114 576304
Why it was recalled
The single use devices are provided sterile and do not have an expiration date on the label.
Root cause (FDA determination)
Labeling Change Control
Action the firm took
Smith & Nephew, Inc. initiated recall by letter on 2/2/17 advising of the problem, requesting inspection of inventory and return of product. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela
Timeline
- Recall initiated
- 2017-02-02
- Terminated
- 2019-09-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #153151. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.