FDA recall Z-2481-2023

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

Status

Ongoing

Initiation date

2023-07-26

Report date

2023-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2481-2023