# FDA recall Z-1845-2021

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2021-05-07.

## 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.

## Distribution

Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda

## Key facts

- **Recall number:** Z-1845-2021
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-07
- **Report date:** 2021-06-16
- **Termination date:** 2023-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1845-2021

## Citation

> AI Analytics. FDA recall Z-1845-2021. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1845-2021. Source: US FDA. Licensed CC0.

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