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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 Recall
DePuy Mitek Sterile Reamers
see related information
Date Posted December 17, 2012
Recall Status1 Terminated 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, Massachusetts 02767
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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