# FDA recall Z-0475-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-08-07.

## Product

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM

## Reason for recall

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

## Distribution

US nationwide distribution. Also Portugal and the Netherlands.

## Key facts

- **Recall number:** Z-0475-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-07
- **Report date:** 2018-02-07
- **Termination date:** 2019-03-29

- **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-0475-2018

## Citation

> AI Analytics. FDA recall Z-0475-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0475-2018. Source: US FDA. Licensed CC0.

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