# FDA recall Z-2067-2023

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2022-12-23.

## Product

LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients.  Product Code: 880-307/21

## Reason for recall

Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

## Distribution

US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.

## Key facts

- **Recall number:** Z-2067-2023
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-23
- **Report date:** 2023-07-12

- **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-2067-2023

## Citation

> AI Analytics. FDA recall Z-2067-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2067-2023. Source: US FDA. Licensed CC0.

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