# FDA recall Z-1734-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-03-28.

## Product

Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.

## Reason for recall

Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.

## Distribution

Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.

## Key facts

- **Recall number:** Z-1734-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-28
- **Report date:** 2018-05-16
- **Termination date:** 2019-03-29

- **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-1734-2018

## Citation

> AI Analytics. FDA recall Z-1734-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1734-2018. Source: US FDA. Licensed CC0.

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