# FDA recall Z-2481-2023

> **Waldemar Link GmbH & Co. KG (Mfg Site)** · Class II · device recall initiated 2023-07-26.

## Product

Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure  Item Number: 17-5220/01

## Reason for recall

A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery

## Distribution

IN,GA, TX

## Key facts

- **Recall number:** Z-2481-2023
- **Recalling firm:** Waldemar Link GmbH & Co. KG (Mfg Site)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-26
- **Report date:** 2023-09-06

- **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-2481-2023

## Citation

> AI Analytics. FDA recall Z-2481-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2481-2023. Source: US FDA. Licensed CC0.

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