| | Class 2 Recall
NOVATION CROWN CUP +5mm LATERALIZED LINER |  |
| Date Posted |
February 05, 2013 |
| Recall Number |
Z-0788-2013 |
| Product |
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. |
| Code Information |
Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.
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Recalling Firm/
Manufacturer |
Exactech, Inc.
2320 NW 66th Ct
Gainesville, Florida 32653-1630 |
Reason for
Recall |
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.
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| 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 in Commerce |
26 Units |
| Distribution |
Distributed in the states of TN, FL, VA, WA and NV. |
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