DePuy Orthopaedics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0038-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 3, 2014

Date Posted: October 15, 2014

Recall Number: Z-0038-2015

Event ID: 69104

Reason for Recall:

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

Status: Terminated

Product Quantity: 875 units

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated