Medical Device Recall: Z-0013-2011

FDA Recalls dataset · Firm: Depuy Orthopaedics, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2010-06-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0013-2011.

Recall Res Number
Z-0013-2011
Recalling Firm / Manufacturer
FEI Number
1818910
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-06-15
Date Posted
2010-10-06
Date Terminated
2011-11-30
Product Code
LXH
Event Number
56026
Product Quantity
8358
Product Description 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.

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 Details 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.

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.

Code Information / Serial Numbers Catalog Number: 2570-00-000 Lot Numbers: A1109, A1209, A0210, A0310

Related Establishments / Registrations

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