FDAFDA · Food and drugs·Recall number Z-0038-2015
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.
Published October 15, 2014 · Recall initiated: September 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- 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.
- Lot
- J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586, NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023, 578910, 578913, R578910, R578912, R578913, 582631, and 592125.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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