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U.S. Department of Health and Human Services

Class 3 Device Recall DePuy Mitek Bioknotless Anchor

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  Class 3 Device Recall DePuy Mitek Bioknotless Anchor see related information
Date Initiated by Firm February 17, 2006
Date Posted March 15, 2006
Recall Status1 Terminated 3 on June 28, 2006
Recall Number Z-0610-06
Recall Event ID 34684
510(K)Number K002639  
Product Classification Fastener, Fixation, Biodegradable, Soft Tissue - Product Code MAI
Product Depuy Mitek Bioknotless Anchor with Ethibond Suture
Ref No. 212728
Code Information Lot Number: 1358481 Exp Date: Nov 2008
Recalling Firm/
Manufacturer		 Depuy Mitek, a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact James Kinney
508-828-2726
Manufacturer Reason
for Recall		 The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
FDA Determined
Cause 2		 Other
Action Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.
Quantity in Commerce 200 pieces
Distribution Nationwide
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 = MAI and Original Applicant = MITEK PRODUCTS
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