# FDA recall Z-0397-2019

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-08-22.

## Product

Biomet Microfixation RapidFlap System	  20MM RapidFlap SpinDown Clamp	  Ref Number: 75-1040  Used for the re-attachment of the bone flap after a craniotomy.

## Reason for recall

Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.

## Distribution

Worldwide distribution:  US Nationwide,    Canada  Argentina  Australia  Belgium  Brazil  Chile  Colombia  Costa Rica  Czech Republic  Dominican Republic  Ecuador  Finland  France  China  Ecuador  Germany  Greece  Hong Kong  Indonesia  Italy  Japan  Jordan  Korea  Lebanon  Malaysia  Netherland  Paraguay  Peru  Singapore  South Africa  Spain  Sweden  Switzerland  Thailand  Trinidad and Tobago  Turkey  United Arab Emirates  United Kingdom  Uruguay  Vietnam

## Key facts

- **Recall number:** Z-0397-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-22
- **Report date:** 2018-11-14
- **Termination date:** 2021-06-17

- **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-0397-2019

## Citation

> AI Analytics. FDA recall Z-0397-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0397-2019. Source: US FDA. Licensed CC0.

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