ReClaim Reamer Extension — Class II medical device recall Z-0972-2013
Terminated recall by DePuy Orthopaedics, Inc., reported 2013-03-27, distributed in AR, AZ, CA, CO, FL, GA, HI, IA…. The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the
| Recall number | Z-0972-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-02-25 |
| Classified | 2013-03-20 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2013-12-30 |
| Distributed | AR, AZ, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, ME, MI, MN, MT, NC, NV, NY, OH, PA, TN, TX, VA, WA, WI |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CZ, DE, FR, GB, IE, IL, NO, NZ, PL, SI, ZA |
| Quantity | 750 |
| Lot numbers | 000003583, 2975-50-025, 578910, 578913, 582631, 592125, 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, R578910, R578912 and 1 more |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0972-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.