| Class 2 Device Recall Novation Crown Cup Connection GXL Neutral Liners | |
Date Initiated by Firm | November 05, 2012 |
Date Posted | February 05, 2013 |
Recall Status1 |
Terminated 3 on December 24, 2013 |
Recall Number | Z-0787-2013 |
Recall Event ID |
64028 |
510(K)Number | K070479 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
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Product | Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53.
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. |
Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 NW 66th Ct Gainesville FL 32653-1630
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For Additional Information Contact | 352-377-1140 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 26 Units |
Distribution | Distributed in the states of TN, FL, VA, WA and NV. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LZO
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