Recall Z-0131-2014 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew Inc
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
| Date | Nov 1, 2013 (initiated Oct 7, 2013) |
| Status | Terminated |
| Reason | Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. |
| Root cause | Process control |
| Action | Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566- |
| Quantity | 4 units |
| Distribution | USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951987 | GENESIS II TOTAL KNEE SYSTEM Smith & Nephew Richards, Inc., Aug 22, 1995 |