Recall Z-0446-2014 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
| Date | Dec 4, 2013 (initiated Aug 27, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Package design/selection |
| Action | 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 w |
| Quantity | 80 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, Germany and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032295 | GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT Smith & Nephew, Inc., Aug 21, 2003 |