Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exac
FDA device recall Z-0788-2013 · posted 2013-02-05 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 26 Units
- Distribution
- Distributed in the states of TN, FL, VA, WA and NV.
- Date initiated
- 2012-11-05
- Date posted
- 2013-02-05
- Date terminated
- 2013-12-24
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTECH NOVATION CROWN CUP AND LINERS (K070479) | Exactech, Inc. | 2007-03-15 |