# FDA recall Z-0527-2020

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

## Product

Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641  11-114642  11-114643  11-114644  11-114644S  11-114645  11-114646  11-114647  11-114648  11-114661  11-114662  11-114663  11-114664  11-114664S  11-114665  11-114666  11-114667  11-114668  11-114632  11-114633  Product Usage: Partial 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-0527-2020
- **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-0527-2020

## Citation

> AI Analytics. FDA recall Z-0527-2020. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0527-2020. Source: US FDA. Licensed CC0.

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