# FDA recall Z-0528-2020

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

## Product

HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit)    Item Nos: HAA60-09030  HAA60-09040  HAA60-10030  HAA60-10040  HAA60-11030  HAA60-11040  HAA60-11050  HAA60-12040  HAA60-12060  HAA60-13030  HAA60-13040  HAA60-13050  HAA60-13060  HAA60-13070  HAA60-14050  HAA60-14080  HAA60-14090  HAA60-15020  HAA60-15030  HAA60-15040  HAA60-15050  HAA60-15060  HAA60-16030  HAA60-16040  HAA60-16050  HAA60-16070  HAA60-16090  HAA60-17040  HAA60-17060  HAA60-17080  HAA60-18010  HAA60-18030  HAA60-18040  HAA60-18050  HAA60-18060  HAA60-18090  HAA60-20030  HAA60-20040  HAA60-20050  HAA60-20060  HAA60-20080  HAA60-20090  HAA60-22050  HAA60-22060  HAA60-25030  HAA60-25040  HAA60-25050  HAA60-25060  HAA60-30060  HAB60-09030  HAB60-10030  HAB60-10040  HAB60-11040  HAB60-11050  HAB60-12040  HAB60-12060  HAB60-13040  HAB60-13050  HAB60-13060  HAB60-14050  HAB60-15060  HAB60-16070  HAB60-16090  HAB60-17080  HAB60-18010  HAB60-18090  HAB60-20080  HAB60-20090  808200000  Product Us

## 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-0528-2020
- **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-0528-2020

## Citation

> AI Analytics. FDA recall Z-0528-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0528-2020. Source: US FDA. Licensed CC0.

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