# FDA recall Z-0533-2020

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

## Product

BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products      Item Nos.  PM0000097  PM555140  PM555147  PM555319  PM555418  113867  113865  113863  Product Usage: Total Shoulder 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-0533-2020
- **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-0533-2020

## Citation

> AI Analytics. FDA recall Z-0533-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0533-2020. Source: US FDA. Licensed CC0.

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