Z-0038-2015 Class II Terminated
FDA device recall Z-0038-2015 was initiated by DePuy Orthopaedics, Inc. on Sep 3, 2014 and is designated Class II. Reason for recall: Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient. The recall status is terminated (terminated Nov 9, 2015). Affected quantity: 875 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 15, 2014
- Initiation Date
- Sep 3, 2014
- Termination Date
- Nov 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 875 units
Product Description
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.
Reason for Recall
Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
Distribution Pattern
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0038-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026