# FDA recall Z-2521-2018

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2018-06-21.

## Product

CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

## Reason for recall

Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.

## Distribution

Accounts in AL, CA, CO, GA< IL, LA, ME, NC, NH, NY, OR, TX, UT, and WA. Foreign distribution to Belgium, Croatia, Cyprus, Denmark, Germany, Indonesia, Korea, Sweden, and Tunisia.

## Key facts

- **Recall number:** Z-2521-2018
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-21
- **Report date:** 2018-08-01
- **Termination date:** 2020-04-06

- **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-2521-2018

## Citation

> AI Analytics. FDA recall Z-2521-2018. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2521-2018. Source: US FDA. Licensed CC0.

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