# FDA recall Z-0642-2019

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-10-12.

## Product

Zimmer Compress Devices and Instruments:  Item Number/Item Description  178350 Compress Device Anti-Rotation Spindle  178353 Compress Device Anti-Rotation Spindle  178356 Compress Device Anti-Rotation Spindle  178359 Compress Device Anti-Rotation Elliptical Spindle  178537 Compress Device Centering Sleeve 15mm  178541 Compress Device Centering Sleeve 19mm  178545 Compress Device Centering Sleeve 23mm  178544 Compress Device Centering Sleeve 22mm  178738 Compress Device Centering Sleeve 28mm  178542 Compress Device Centering Sleeve 20mm  32-481123 Compress Instrument Drill For Anti-Rotation Pin  178757  Mini Taper Spindle, 400 lbs, Extra Small  178758  Mini Taper Spindle, 600 lbs, Extra Small  178759  Mini Taper Spindle, 800 lbs, Extra Small  178787  Short Mini Taper Spindle, 400 lbs, Extra Small  178788  Short Mini Taper Spindle, 600 lbs, Extra Small  178789  Short Mini Taper Spindle, 800 lbs, Extra Small

## Reason for recall

Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.

## Distribution

Nationwide  Foreign:  CANADA  ARGENTINA  AUSTRALIA  BELGIUM  CHILE            FINLAND  JAPAN               NETHERLANDS

## Key facts

- **Recall number:** Z-0642-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-12
- **Report date:** 2018-12-26
- **Termination date:** 2020-04-17

- **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-0642-2019

## Citation

> AI Analytics. FDA recall Z-0642-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0642-2019. Source: US FDA. Licensed CC0.

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