# FDA recall Z-2289-2025

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2025-07-15.

## Product

Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

## Reason for recall

Inconsistent size terminology and color coding used on labeling

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.

## Key facts

- **Recall number:** Z-2289-2025
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-15
- **Report date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norderstedt, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2289-2025

## Citation

> AI Analytics. FDA recall Z-2289-2025. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2289-2025. Source: US FDA. Licensed CC0.

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