Recall Z-2199-2010 ยท HTY Pin, Fixation, Smooth
Smith & Nephew Inc
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 & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation
| Date | Aug 10, 2010 (initiated Jun 28, 2010) |
| Status | Terminated |
| Reason | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 8 units |
| Distribution | KY, TX, DC, NC, CA, AZ, GA and OH; 3 International: Australia, Malaysia, and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.