# FDA recall Z-1298-2024

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2024-02-06.

## Product

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

## Reason for recall

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

## Distribution

US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.

## Key facts

- **Recall number:** Z-1298-2024
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-06
- **Report date:** 2024-03-20

- **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-1298-2024

## Citation

> AI Analytics. FDA recall Z-1298-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1298-2024. Source: US FDA. Licensed CC0.

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