Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Nu

FDA device recall Z-0013-2011 · posted 2010-10-06 · Terminated

Recall details

Recalling firm

Depuy Orthopaedics, Inc.

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).

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

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.

Date initiated

2010-06-15

Date posted

2010-10-06

Date terminated

2011-11-30

Location

Warsaw, IN