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U.S. Department of Health and Human Services

Class 3 Device Recall DePuy Mitek

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  Class 3 Device Recall DePuy Mitek see related information
Date Initiated by Firm August 09, 2005
Date Posted November 18, 2005
Recall Status1 Terminated 3 on May 02, 2006
Recall Number Z-0161-06
Recall Event ID 32951
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm
Catalog Number : 232220
Code Information Lot Number: JBV04259
Recalling Firm/
Manufacturer		 Depuy Mitek, a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact Jim Kenney
508-828-2726
Manufacturer Reason
for Recall		 Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer
FDA Determined
Cause 2		 Other
Action DePuy Mitek notified the accounts by US Mail on 8/09/05. Accounts were requested to return product.
Quantity in Commerce 5 boxes /10 units (50 pieces)
Distribution CA, NC, VA
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.
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