# FDA recall Z-0521-2020

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2019-08-21.

## Product

ACROMIUM FLANGE SET (Custom product)  Item No. PM555148 - Product Usage: Arcomium replacement.

## Reason for recall

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

## Distribution

US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.

## Key facts

- **Recall number:** Z-0521-2020
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-21
- **Report date:** 2019-12-04
- **Termination date:** 2021-07-21

- **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-0521-2020

## Citation

> AI Analytics. FDA recall Z-0521-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0521-2020. Source: US FDA. Licensed CC0.

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