GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc
FDA device recall Z-0448-2014 · posted 2013-12-04 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
- Action taken
- Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email. For questions regarding this recall call 901-396-2121.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 46 pieces
- Distribution
- Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, G
- Date initiated
- 2013-08-27
- Date posted
- 2013-12-04
- Date terminated
- 2019-08-20
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT (K032295) | Smith & Nephew, Inc. | 2003-08-21 |