# FDA recall Z-0575-2021

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2020-11-19.

## Product

DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE	-Orthopedic manual surgical instrument  Part Code: 03.404.020S

## Reason for recall

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

## Distribution

Nationwide  Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,

## Key facts

- **Recall number:** Z-0575-2021
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-19
- **Report date:** 2020-12-23
- **Termination date:** 2022-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0575-2021

## Citation

> AI Analytics. FDA recall Z-0575-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0575-2021. Source: US FDA. Licensed CC0.

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