Recalls / —
—#92887
Product
CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation
- FDA product code
- JDQ — Cerclage, Fixation
- Device class
- Class 2
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot Number: 10DM13784
Why it was recalled
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.
Root cause (FDA determination)
Process control
Action the firm took
All affected Smith & Nephew Sales Representatives were notified of problem and the recall was sent via overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E. Brooks Rd, Memphis, Tennessee 38116
Distribution
- Distribution pattern
- KY, TX, DC, NC, CA, AZ, GA and OH; 3 International: Australia, Malaysia, and Switzerland
Timeline
- Recall initiated
- 2010-06-28
- Posted by FDA
- 2010-08-10
- Terminated
- 2012-01-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #92887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.