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U.S. Department of Health and Human Services

Class 3 Device Recall Mitek Profile

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  Class 3 Device Recall Mitek Profile see related information
Date Initiated by Firm February 28, 2003
Date Posted April 01, 2003
Recall Status1 Terminated 3 on February 04, 2004
Recall Number Z-0699-03
Recall Event ID 25698
510(K)Number K982662  
Product Classification Screw, Fixation, Bone - Product Code HWC
Product Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head
Product Reference No.: 230420
Code Information Lot Number: 0301594
Recalling Firm/
Manufacturer		 Mitek Worldwide
249 Vanderbilt Drive
Norwood MA 02062
For Additional Information Contact James Kenney
781-251-3102
Manufacturer Reason
for Recall		 Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm
FDA Determined
Cause 2		 Other
Action Mitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03.
Quantity in Commerce 20
Distribution CO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK,
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 = HWC and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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