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U.S. Department of Health and Human Services

Class 2 Device Recall Novation 12/14 Pressfit Femoral Stem

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  Class 2 Device Recall Novation 12/14 Pressfit Femoral Stem see related information
Date Initiated by Firm March 07, 2014
Date Posted July 21, 2014
Recall Status1 Terminated 3 on August 04, 2014
Recall Number Z-2086-2014
Recall Event ID 68341
510(K)Number K042843  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13

intended to be implanted to replace a hip joint with our without bone cement.
Code Information Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Kaya Davis
800-392-2832
Manufacturer Reason
for Recall		 The femoral stem is lacking specified plasma coating.
FDA Determined
Cause 2		 Component design/selection
Action Exactech sent an Important Product Recall Notice dated March 10, 2014, to all affected customers. The notice identified the product the problem and the action to be taken by the customer. Description of Issue: The femoral stem is lacking specified plasma spray coating. Clinical Impact: Without plasma spray coating, the stem may not remain stable and will not have the possibility for biological fixation. In order to comply with applicable regulations and Exactech policies customers were instructed to : " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Determine if they have any of the affected devices " Fax back the attached form. Complete the attached fax back form and return it to Exactech. Customers were instructed to contact their Exactech inventory representative within 5 business days to confirm quantities at their location. For any inventory restocking questions related to this issue, please call 1-800-392-2832. For questions regarding this recall call 800-392-2832.
Quantity in Commerce 10
Distribution Worldwide Distribution including Spain, Greece and Japan
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LZO and Original Applicant = AMBU, INC.
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