| | Class 2 Recall
PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE |  |
| Date Posted |
August 31, 2010 |
| Recall Number |
Z-2314-2010 |
| Product |
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. |
| Code Information |
Lot number 08GM01779
|
Recalling Firm/
Manufacturer |
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis, Tennessee 38116 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Dave Archer
901-399-5427
|
Reason for
Recall |
Inner packaging of sterile product was not sealed. Lack of sterility assurance.
|
| 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 notify anyone to whom the product was distributed to also contact the firm for return of the product. Smith & Nephew can be contacted at 1-901-399-5441. |
| Quantity in Commerce |
10 units |
| Distribution |
Worldwide Distribution: INTERNATIONAL ONLY: Countries of China, UK, Italy, Australia, and South Africa |
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