Recall Z-2198-2010 ยท JDQ Cerclage, Fixation
Smith & Nephew Inc
CERCLAGE WIRE, 0.8 MM DIA. X 200 MM LENGTH, SST, REF 71163008, 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
| 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 | 34 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.