CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc
FDA device recall Z-2197-2010 · posted 2010-08-10 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JDQ
- Quantity affected
- 1 unit
- Distribution
- KY, TX, DC, NC, CA, AZ, GA and OH; 3 International: Australia, Malaysia, and Switzerland
- Date initiated
- 2010-06-28
- Date posted
- 2010-08-10
- Date terminated
- 2012-01-23
- Location
- Memphis, TN
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