# FDA recall Z-0769-2025

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2024-12-05.

## Product

LINK MP Reconstruction System  Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14.     Item Number: 99-0984/32    Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.

## Reason for recall

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

## Distribution

US Nationwide distribution in the states of AL, FL.

## Key facts

- **Recall number:** Z-0769-2025
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-05
- **Report date:** 2025-01-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0769-2025

## Citation

> AI Analytics. FDA recall Z-0769-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0769-2025. Source: US FDA. Licensed CC0.

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