# FDA recall Z-0269-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-06-16.

## Product

ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610.    The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek¿ lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek¿ lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.

## Reason for recall

Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.

## Distribution

US, Canada, OUS.

## Key facts

- **Recall number:** Z-0269-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-16
- **Report date:** 2017-12-27
- **Termination date:** 2018-09-06

- **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-0269-2018

## Citation

> AI Analytics. FDA recall Z-0269-2018. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0269-2018. Source: US FDA. Licensed CC0.

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