RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to al

FDA device recall Z-0038-2015 · posted 2014-10-08 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.

Action taken

On February 25, 2013, DePuy Orthopaedics, Inc. issued a device correction for the specific lots of the RECLAIM Distal Reamer Extension impacted by this recall. The letter stated the reason for the recall and swap out. A subsequent letter outlined a formal swap-out process of the affected reamer extensions as part of the device correction strategy. Newly designed devices are now available. Questions about device swap-out information may be directed to Kim Earle, Recall Coordinator, 574-371-4917; and Surgeon questions may be directed to DePuy's Scientific Information Office at 1-888-554-2482.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

875 units

Distribution

Worldwide Distribution -- USA, including the states of ME, MD, PA, MA, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, NC, VA, NY, TN, and IN; and, the countries of Canada, Aus

Date initiated

2014-09-03

Date posted

2014-10-08

Date terminated

2015-11-09

Location

Warsaw, IN