# FDA recall Z-1029-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-11-29.

## Product

VERSYS 8 INCH BEADED FC   12X200MM STR STD BODY/NECK  13X200MM STR STD BODY/NECK  14X200MM STR STD BODY/NECK  REV 13.5X200MM BWD LT  15X200MM STR STD BODY/NECK  REV 13.5X200MM BWD RT  REV 15.0X200MM BWD LT  REV 15.0X200MM BWD RT  REV 16.5X200MM BWD LT  REV 16.5X200MM BWD RT    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

## Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

## Key facts

- **Recall number:** Z-1029-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-29
- **Report date:** 2018-03-21
- **Termination date:** 2020-04-02

- **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-1029-2018

## Citation

> AI Analytics. FDA recall Z-1029-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1029-2018. Source: US FDA. Licensed CC0.

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