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U.S. Department of Health and Human Services

Class 2 Device Recall ReClaim Reamer Extension

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  Class 2 Device Recall ReClaim Reamer Extension see related information
Date Initiated by Firm February 25, 2013
Date Posting Updated March 20, 2013
Recall Status1 Terminated 3 on December 30, 2013
Recall Number Z-0972-2013
Recall Event ID 64285
Product Classification Reamer - Product Code HTO
Product ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
Code Information Engraved Lot Number/ Label Lot Number, J0111 / 578910, 578913, R578910, R578912, R578913, In Kit # 2975-50-025, J0211/ In Kit # 2975-50-025, J0411/ 582631, In Kit # 2975-50-025, J0611/ In Kit # 2975-50-025, J0911/ 592125, In Kit # 2975-50-025, J1211/ 000003583, In Kit # 2975-50-025, NB12649 / NB12649, NB12650 / NB12650, NB12651 / NB12651, NB12652 / NB12652, NB12653/ NB12653, NB12654/ NB12654, NB12655/ NB12655, NB12656/ NB12656, NB23480/ NB23480, NB23481/ NB23481, NB3584 / In Kit # 2975-50-025, NB3586 / NB3586, NB3587 / NB3587, NB3588 / In Kit # 2975-50-025, NB3590 / NB3590, NB3591 / In Kit # 2975-50-025, NB5955 / NB5955, NB7894 / NB7894, In Kit # 2975-50-025, NB8016 / In Kit # 2975-50-025, NB8017 / NB8017, NB8018 / NB8018, In Kit # 2975-50-025, NB8019 / In Kit # 2975-50-025, NB8020 / NB8020, NB8021 / NB8021, NB8022 / NB8022, NB8023 /NB8023.
Recalling Firm/
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Mindy Tinsley
Manufacturer Reason
for Recall
The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.
FDA Determined
Cause 2
Device Design
Action DePuy Synthes sent a Urgent Information Medical Device Correction Notice to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed upon visual inspection, if the reamer extension is found to have one or more tabs broken, please do not use the reamer extension. The reamer extension will still engage with one tab intact and no clinical implications have been identified with the use of the reamer extension with one tab, but DePuy recommends it be returned and the alternate reamer extension device be used. If both tabs are broken, the reamer extension will not engage and DePuy recommends it be returned and the alternate reamer extension device be used. A reamer extractor is available in the instrument kit for removal of the reamer if necessary. In order to reduce the risk of breaking the tabs during surgery, the Reamer Extension should only be used to drive the Distal Reamer axially within the patients femoral canal. The instrument is NOT intended to be used for side-cutting or lateralizing the femoral canal, therefore, no off-axis force should be applied during distal reaming. The purpose of this communication is to inform you of this device correction and request acknowledgement of receipt of this letter by signing and returning the Surgeon Response Card within 14 days of receiving this notice. Response cards should be faxed to Fax Number: 574-371-4939. For product-related questions, please contact your local DePuy Orthopaedics Sales Representative. For clinical-related questions from surgeons, please have them contact DePuys Scientific Information Office at 1-888-554-2482 (M-F; 8 am to 5 pm EST.) For questions about device correction information provided, 574-372-7333 (M-F: 8 am to 5 pm EST.)
Quantity in Commerce 750
Distribution Worldwide Distribution - USA including the states of ME, MA, PA, MD, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, TN, NY, AR, NC and VA and the countries of Canada, Chile, Germany, Czech Republic, Israel , Norway, Poland, Slovenia, Australia, New Zealand, South Africa, Belgium, Austria, Switzerland, France, England and County Cork, Ireland.
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.