# FDA recall Z-0322-2020

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2019-10-10.

## Product

Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100  00579104200  00579104300  00579104400  00579105400  00597909526  00597909529  00597909532  00597909535  00597909538  00597909541  00597909546  00597909551  00598304027  00598304033  00598304048  00598304148

## Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## Distribution

Distributed nationwide.

## Key facts

- **Recall number:** Z-0322-2020
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-10
- **Report date:** 2019-11-13
- **Termination date:** 2020-05-19

- **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-0322-2020

## Citation

> AI Analytics. FDA recall Z-0322-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0322-2020. Source: US FDA. Licensed CC0.

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