# FDA recall Z-0523-2020

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

## Product

Various Hip systems, Item Nos. 104207  104212  104215  11-162809  11-162810  11-162811  11-162812  11-162813  21-103202  21-103203  21-103204  21-103205  21-103206  21-103207  21-103208  21-103209  21-103210  21-103211  21-103212  21-103215  21-104109  21-104110  21-104111  21-104112  21-104113  21-104114  21-104115  21-104116  21-104117  21-104118  21-104119  21-108110  21-108112  21-108115  21-108117  21-108119  21-108130  21-108132  21-108135  21-108137  21-108139  21-108150  21-108152  21-108155  21-108157  21-108159  21-108251  21-108253  21-108255  21-108257  21-108259  21-108271  21-108273  21-108275  21-108277  21-108279  21-108291  21-108293  21-108295  21-108297  21-108299  21-108391  21-108393  21-108395  21-108397  21-108399  21-109256  21-109260  21-109264  21-109268  21-109272  21-123202  21-123203  21-123204  21-123205  21-123206  21-123207  21-123208  21-123209  21-123210  21-123211  21-123212  21-124309  21-124310  21-124311  21-124312  21-124313  21-124314  21-124315 

## 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-0523-2020
- **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-0523-2020

## Citation

> AI Analytics. FDA recall Z-0523-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0523-2020. Source: US FDA. Licensed CC0.

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