Date Initiated by Firm | February 17, 2006 |
Date Posted | March 15, 2006 |
Recall Status1 |
Terminated 3 on June 28, 2006 |
Recall Number | Z-0611-06 |
Recall Event ID |
34684 |
510(K)Number | K002639 |
Product Classification |
Fastener, Fixation, Biodegradable, Soft Tissue - Product Code MAI
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Product | Depuy Mitek Bioknotless Anchor with Panacryl Suture
Ref No. 212729 |
Code Information |
Lot Number: 1359592 Exp. date Nov 2008 |
Recalling Firm/ Manufacturer |
Depuy Mitek, a Johnson & Johnson Co. 325 Paramount Dr Raynham MA 02767-5199
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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 |
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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 = MAI
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