ClearanceBrief
Recall Z-0038-2015 ยท LXH Orthopedic Manual Surgical Instrument

DePuy Orthopaedics, Inc.

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.

DateOct 8, 2014 (initiated Sep 3, 2014)
StatusTerminated
ReasonSpecific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
Root causeDevice Design
ActionOn 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.
Quantity875 units
DistributionWorldwide 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 Zeal
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.