# FDA recall Z-1705-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-04-05.

## Product

Lactosorb RapidFlap, bone plate, Model No. 915-0020    The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.

## Reason for recall

The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.

## Distribution

worldwide Distribution - US Distribution to the states of : CA, FL, MO, NC, SC, TX, and WI., and to the countries of :  Argentina, China, Colombia, Germany, Japan, Netherlands, South Africa, Thailand, and Vietnam.

## Key facts

- **Recall number:** Z-1705-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-05
- **Report date:** 2018-05-16
- **Termination date:** 2020-08-12

- **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-1705-2018

## Citation

> AI Analytics. FDA recall Z-1705-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1705-2018. Source: US FDA. Licensed CC0.

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