# FDA recall Z-1054-2018

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

## Product

ZUK PRC FEM SZB RMED/LLAT¿  ZUK PRC FEM SZC LMED/RLAT¿  ZUK PRC FEM SZC RMED/LLAT¿  NGU PRC FEM SZD LMED/RLAT¿  ZUK PRC FEM SZD RMED/LLAT¿  ZUK PRC FEM SZE LMED/RLAT  ZUK PRC FEM SZF RMED/LLAT    " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

## 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-1054-2018
- **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-1054-2018

## Citation

> AI Analytics. FDA recall Z-1054-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1054-2018. Source: US FDA. Licensed CC0.

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