DePuy Orthopaedics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0972-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.

Product Classification:

Class II

Date Initiated: February 25, 2013

Date Posted: March 27, 2013

Recall Number: Z-0972-2013

Event ID: 64285

Reason for Recall:

The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.

Status: Terminated

Product Quantity: 750

Code Information:

Engraved Lot Number/ Label Lot Number J0111 / 578910 578913 R578910 R578912 R578913 In Kit # 2975-50-025 J0211/ In Kit # 2975-50-025 J0411/ 582631 In Kit # 2975-50-025 J0611/ In Kit # 2975-50-025 J0911/ 592125 In Kit # 2975-50-025 J1211/ 000003583 In Kit # 2975-50-025 NB12649 / NB12649 NB12650 / NB12650 NB12651 / NB12651 NB12652 / NB12652 NB12653/ NB12653 NB12654/ NB12654 NB12655/ NB12655 NB12656/ NB12656 NB23480/ NB23480 NB23481/ NB23481 NB3584 / In Kit # 2975-50-025 NB3586 / NB3586 NB3587 / NB3587 NB3588 / In Kit # 2975-50-025 NB3590 / NB3590 NB3591 / In Kit # 2975-50-025 NB5955 / NB5955 NB7894 / NB7894 In Kit # 2975-50-025 NB8016 / In Kit # 2975-50-025 NB8017 / NB8017 NB8018 / NB8018 In Kit # 2975-50-025 NB8019 / In Kit # 2975-50-025 NB8020 / NB8020 NB8021 / NB8021 NB8022 / NB8022 NB8023 /NB8023

Distribution Pattern:

Worldwide Distribution - USA including the states of ME, MA, PA, MD, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, TN, NY, AR, NC and VA and the countries of Canada, Chile, Germany, Czech Republic, Israel , Norway, Poland, Slovenia, Australia, New Zealand, South Africa, Belgium, Austria, Switzerland, France, England and County Cork, Ireland.

Voluntary or Mandated:

Voluntary: Firm initiated