# FDA recall Z-1219-2024

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2024-01-22.

## Product

LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur.  Item Number: 184-280/12

## Reason for recall

Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

## Distribution

Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.

## Key facts

- **Recall number:** Z-1219-2024
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-22
- **Report date:** 2024-03-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1219-2024

## Citation

> AI Analytics. FDA recall Z-1219-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1219-2024. Source: US FDA. Licensed CC0.

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