DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer… — Class II medical device recall Z-1845-2021
Terminated recall by DePuy Orthopaedics, Inc., reported 2021-06-16, distributed in CA, CT, FL, GA, IA, IN, LA, ME…. Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched
| Recall number | Z-1845-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2021-05-07 |
| Classified | 2021-06-10 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2023-03-09 |
| Distributed | CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI |
| Countries outside the US | BM |
| Quantity | 50 units |
| UPC / GTIN / UDI-DI | 10603295033172 |
| Lot numbers | D20111130 |
| Model numbers | 1365-21-000 |
Product
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
Reason for recall
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
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-1845-2021. 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.