# FDA recall Z-1014-2018

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

## Product

BIPOLAR METAL SHELL 48 MM OD    Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement

## 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-1014-2018
- **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-1014-2018

## Citation

> AI Analytics. FDA recall Z-1014-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-1014-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*