# FDA recall Z-1061-2018

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

## Product

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿  N-K FLX GSM POR FEM SZ 2 RT     N-K FLX GSM POR FEM SZ 3 LT     N-K FLX GSM POR FEM SZ 4 LT     N-K FLX GSM POR FEM SZ 4 RT     N-K FLX GSM POR FEM SZ 5 LT     N-K FLX GSM POR FEM SZ 5 RT         Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

## 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-1061-2018
- **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-1061-2018

## Citation

> AI Analytics. FDA recall Z-1061-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1061-2018. Source: US FDA. Licensed CC0.

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