Recall Z-0788-2013 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Exactech, Inc.
Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
| Date | Feb 5, 2013 (initiated Nov 5, 2012) |
| Status | Terminated |
| Reason | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed. |
| Root cause | Labeling mix-ups |
| Action | Exactech, Inc. notified consignees by telephone on 11/05/12 of the affected devices and sent an "IMPORTANT PRODUCT RECALL NOTICE" letter dated 11/06/12. The letter describes the purpose of the recall, the product affected, the problem and actions to be taken by the consignees. A Product Recall Response Form was attached for the consignees to contact the Exactech inventory representative within 5 business days to confirm quantities of product in their inventory and return them to Exactech. Consignees with any questions relating to these devices should call 1-800-392-2832. |
| Quantity | 26 Units |
| Distribution | Distributed in the states of TN, FL, VA, WA and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070479 | EXACTECH NOVATION CROWN CUP AND LINERS Exactech, Inc., Mar 15, 2007 |