Waldemar Link GmbH & Co. KG (Mfg Site): Medical Device Recall in 2023 - (Recall #: Z-2481-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 26, 2023

Date Posted: September 6, 2023

Recall Number: Z-2481-2023

Event ID: 92839

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

Status: Ongoing

Product Quantity: 6 units

Code Information:

UDI-DI: 04026575284658 Lot Codes: C010108, C151519

Distribution Pattern:

IN,GA, TX

Voluntary or Mandated:

Voluntary: Firm initiated