DePuy Orthopaedics, Inc. recalls RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers

Recalled October 15, 2014 · FDA recall Z-0038-2015 · DePuy Orthopaedics

Hazard

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

Units

875 units

Sold at

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, Australia, Austria, Belgium, Czech Republic, United Kingdom, France, Germany, Ireland, Israel, New Zealand, Norway, Poland, Slovenia, South Africa, Switzerland, and Chile.

Description

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

Product

RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.

Manufacturer(s)

DePuy Orthopaedics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →