RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended… — Class II medical device recall Z-0038-2015
Terminated recall by DePuy Orthopaedics, Inc., reported 2014-10-15, distributed in AZ, CA, CO, FL, GA, HI, IA, IL…. Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
| Recall number | Z-0038-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-09-03 |
| Classified | 2014-10-07 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2015-11-09 |
| Distributed | AZ, CA, CO, FL, GA, HI, IA, IL, IN, 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 | 875 units |
| Reason classes | device malfunction |
| Model numbers | 2975-00-500 |
Product
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.
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-0038-2015. 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.