PERI-LOC, 2.0 MM X 228 MM, K-WIRE W/TROCAR POINT, CO-CR, REF 71173361, QTY: (6), STERILE FR, CE 0123, 2015/04, Smith & N
FDA device recall Z-2199-2010 · 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
- HTY
- Quantity affected
- 8 units
- 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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