# FDA recall Z-2105-2023

> **Wright Medical Technology, Inc.** · Class II · device recall initiated 2023-06-13.

## Product

Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

## Reason for recall

The devices were manufactured with the pin sleeve holes too narrow, which does not allow  the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

## Distribution

There was no U.S. distribution, including government and military.    Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.

## Key facts

- **Recall number:** Z-2105-2023
- **Recalling firm:** Wright Medical Technology, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-13
- **Report date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2105-2023

## Citation

> AI Analytics. FDA recall Z-2105-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2105-2023. Source: US FDA. Licensed CC0.

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