FDA-Device2014-10-15Class II
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.
DePuy Orthopaedics, Inc.
Hazard
Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
Sold states
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.
Affected count
875 units
Manufactured in
700 Orthopaedic Dr, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0038-2015Don't want to check this manually?
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