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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Mitek Sterile Reamers

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  Class 2 Device Recall DePuy Mitek Sterile Reamers see related information
Date Initiated by Firm November 16, 2012
Date Posted December 17, 2012
Recall Status1 Terminated 3 on December 21, 2012
Recall Number Z-0529-2013
Recall Event ID 63732
Product Classification Reamer - Product Code HTO
Product DePuy Mitek 11 MM Fully Fluted Reamer, Sterile
Product Number: 232423

DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
Code Information Lot Number: 3611687 
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact
508-880-8100
Manufacturer Reason
for Recall		 Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer
FDA Determined
Cause 2		 Packaging process control
Action DePuy Mitek sent an Urgent Voluntary Product Recall letter dated November 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to refer to the attached instructions to report their inventory status and for returning the affected product. Customers with questions should call 1-508-880-8477. For questions regarding this recall call 508-880-8100.
Quantity in Commerce 20
Distribution Nationwide Distribution including IL and NJ
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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