ClearanceBrief
Recall Z-0013-2011 ยท LXH Orthopedic Manual Surgical Instrument

Depuy Orthopaedics, Inc.

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 c

DateOct 6, 2010 (initiated Jun 15, 2010)
StatusTerminated
ReasonFirm discovered that some of their straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring).
Root causeProcess control
ActionOn 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: Repair
Quantity8358
DistributionNationwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.