---
title: "Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral ... — FDA record Z-2481-2023 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-2481-2023-link-optistem-rasp-handle-used-with-the-optistem-rasp-to-prepare-the-femoral-medullary-canal-for-a-k/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis im... — FDA record Z-2481-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 26, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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
- **Classification**: Class II
- **Recalling firm**: Waldemar Link GmbH & Co. KG (Mfg Site)
- **Quantity**: 6 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2481-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2481-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 04026575284658 Lot Codes: C010108, C151519 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

IN,GA, TX

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Georgia](https://isitonrecall.com/state/georgia/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Sep 6, 2023
- **Recall initiation date**: Jul 26, 2023
- **Center classification date**: Aug 29, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2481-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Waldemar Link GmbH & Co. KG (Mfg Site) records](https://isitonrecall.com/brand/waldemar-link-gmbh-co-kg-mfg-site/)