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U.S. Department of Health and Human Services

Class 2 Device Recall CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach H

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 Class 2 Recall
CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach H
see related information
Date Posted December 27, 2010
Recall Status1 Terminated on March 26, 2014
Recall Number Z-0815-2011
Recall Event ID 57292
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430;
Code Information CuttingEdge Advantage Rasp Handle - Catalog number 1100-1000; All lot codes Straight Rasp Handle - Catalog number 1440-1400; All lot codes Specialty Head Center Accolade Broach Handle - Catalog number I-H088HF00, I-H1389HF00 ; All lot codes
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
The CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach Handle may fracture in two pieces along the width of the body under the striking plate. This may extend surgical time under anesthesia, cause trauma to the surgeon or patient, or contaminate the surgical site.
FDA Determined
Cause 2
DESIGN: Device Design
Action Stryker issued a Product Correction Bulletin dated November 2010 to their consignees, alerting surgeons of the need to inspect the instruments before and after each surgical use, and, if a defect is detected, to contact Stryker for return of the product. Stryker can be contacted at 201 831-5288 concerning this issue. In response to their revised strategy, Stryker issued notification letters and product recall acknowledgement forms to their branches and agencies on 2/17/2011 for 2/18/2011 delivery via Fed Ex and to their hospital risk managers on 2/18/2011 for 2/21/2011 delivery via Fed ex.
Quantity in Commerce 459 units
Distribution Worldwide Distribution: Throughout the US, the countries of Canada and Japan, and the regions of Asia Pacific, Europe, Middle East, Africa, and Latin America.
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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