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U.S. Department of Health and Human Services

Class 2 Device Recall RECLAIM Distal Reamer Extension

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  Class 2 Device Recall RECLAIM Distal Reamer Extension see related information
Date Initiated by Firm September 03, 2014
Date Posted October 08, 2014
Recall Status1 Terminated 3 on November 09, 2015
Recall Number Z-0038-2015
Recall Event ID 69104
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product RECLAIM Distal Reamer Extension
Non Sterile
REF 2975-00-500

Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
Code Information J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586, NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023, 578910, 578913, R578910, R578912, R578913, 582631, and  592125.   
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Tia L. Holmes-Johnson
574-371-4577
Manufacturer Reason
for Recall		 Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
FDA Determined
Cause 2		 Device Design
Action On February 25, 2013, DePuy Orthopaedics, Inc. issued a device correction for the specific lots of the RECLAIM Distal Reamer Extension impacted by this recall. The letter stated the reason for the recall and swap out. A subsequent letter outlined a formal swap-out process of the affected reamer extensions as part of the device correction strategy. Newly designed devices are now available. Questions about device swap-out information may be directed to Kim Earle, Recall Coordinator, 574-371-4917; and Surgeon questions may be directed to DePuy's Scientific Information Office at 1-888-554-2482.
Quantity in Commerce 875 units
Distribution Worldwide Distribution -- USA, including the states of ME, MD, PA, MA, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, NC, VA, NY, TN, and IN; and, the countries of Canada, Australia, Austria, Belgium, Czech Republic, United Kingdom, France, Germany, Ireland, Israel, New Zealand, Norway, Poland, Slovenia, South Africa, Switzerland, and Chile.
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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