—#92444

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number: 2570-00-000 Lot Numbers: A1109, A1209, A0210, A0310

Why it was recalled

Firm discovered that some of their straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring).

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-06-15
Posted by FDA: 2010-10-06
Terminated: 2011-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92444. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.