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U.S. Department of Health and Human Services

Class 2 Device Recall NOVATION CROWN CUP 5mm LATERALIZED LINER

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 Class 2 Device Recall NOVATION CROWN CUP 5mm LATERALIZED LINERsee related information
Date Initiated by FirmNovember 05, 2012
Date PostedFebruary 05, 2013
Recall Status1 Terminated 3 on December 24, 2013
Recall NumberZ-0788-2013
Recall Event ID 64028
510(K)NumberK070479 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductExactech 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.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
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
ActionExactech, 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 Commerce26 Units
DistributionDistributed in the states of TN, FL, VA, WA and NV.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = LZO
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