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Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis impla
Recalled September 6, 2023 · FDA recall Z-2481-2023 · Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard
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 · FDA Class II
Units
6 units
Sold at
IN,GA, TX
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 rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery
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
Manufacturer(s)
Waldemar Link GmbH & Co. KG (Mfg Site)
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →