# FDA recall Z-1372-2025

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2025-02-14.

## Product

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA =  11 mm, Product Code: 880-601/11

## Reason for recall

A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.

## Distribution

Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.

## Key facts

- **Recall number:** Z-1372-2025
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-14
- **Report date:** 2025-03-26

- **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-1372-2025

## Citation

> AI Analytics. FDA recall Z-1372-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1372-2025. Source: US FDA. Licensed CC0.

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