Recall Z-2314-2010 ยท HRS Plate, Fixation, Bone
Smith & Nephew Inc
PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 0086, Smith & Nephew, Inc., Memphis, TN 38116, USA, EC REP: Smith & Nephew Orthopaedics Gmbh, Tuttlingen, Germany. Adult and pediatric patients, as indicated for pelvic, small, and long bone fracture fixation.
| Date | Aug 31, 2010 (initiated Jul 20, 2010) |
| Status | Terminated |
| Reason | Inner packaging of sterile product was not sealed. Lack of sterility assurance. |
| Root cause | Packaging |
| Action | Smith & Nephew issued an "Urgent:: Medical Device Recall" letter dated July 20, 2010 to consignees (International distributors), identifying the issue and affected product. Consignees were requested to identify and quarantine affected stock, and cease distribution. Consignees were instructed to contact Smith and Nephew for a Return Authorization number. The Return Authorization number and an inventory of affected devices are to be recorded on the Verification Section of the notification letter and faxed to the firm. Affected stock is to be sent to Smith & Nephew. Consignees were requested to |
| Quantity | 10 units |
| Distribution | Worldwide Distribution: INTERNATIONAL ONLY: Countries of China, UK, Italy, Australia, and South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033669 | SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) Smith & Nephew, Inc., Dec 10, 2003 |