# FDA recall Z-0519-2020

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

## Product

Compress, Mini Compress; Item Nos. 178350  178351  178352  178353  178354  178355  178356  178357  178358  178359  178360  178361  178362  178363  178364  178365  178366  178367  178368  178369  178370  178371  178372  178373  178464  178472  178480  178488  178496  178504  178575  178576  178577  178578  178579  178580  178730  178731  178732  178733  178734  178735  178354S  178754  178755  178756  178757  178758  178759    Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

## 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-0519-2020
- **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-0519-2020

## Citation

> AI Analytics. FDA recall Z-0519-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0519-2020. Source: US FDA. Licensed CC0.

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