PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 00
FDA device recall Z-2314-2010 · posted 2010-08-31 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Inner packaging of sterile product was not sealed. Lack of sterility assurance.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution: INTERNATIONAL ONLY: Countries of China, UK, Italy, Australia, and South Africa
- Date initiated
- 2010-07-20
- Date posted
- 2010-08-31
- Date terminated
- 2011-11-17
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) (K033669) | Smith & Nephew, Inc. | 2003-12-10 |