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U.S. Department of Health and Human Services

Class 2 Device Recall Summit Universal Broach Handle

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 Class 2 Recall
Summit Universal Broach Handle
see related information
Date Posted October 06, 2010
Recall Status1 Terminated on November 30, 2011
Recall Number Z-0013-2011
Recall Event ID 56026
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.
Code Information Catalog Number: 2570-00-000 Lot Numbers: A1109, A1209, A0210, A0310
Recalling Firm/
Manufacturer
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw, Indiana 46582-3994
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Katherine Seppa
574-372-7333
Manufacturer Reason
for Recall
Firm discovered that some of their straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On June 3, 2010, an "Alert: Femoral Broach Handle Repair" went out to the entire sales force/customers via "Sales Mail" and posted to the DePuy Internal website. The Alert stated that "We have discovered that some of our straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring). As you perform routine maintenance on your sets, if you have any of these broaches stamped with the lot numbers listed, it is recommended you have them sent in to be reworked with a new spring device." Send the broach handles to: DePuy Orthopaedics Attn: Repairs 700 Orthopaedic Dr Warsaw, IN 46581 Please include return shipping information If you have any questions regarding this information or need additional information, call 574-372-7333.
Quantity in Commerce 8358
Distribution Nationwide distribution: AR, AZ, CA, FL, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, NC, NV, NY, OH, PA, TN, VA, and WI.
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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