medical Class II Updated 2023-09-06

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link OptiStem Rasp Handle-Used with the OptiStem Rasp to pre

Recalled 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


Hazard / Issue

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

Issued by

FDA

Affected States: IN, GA, TX
Lot/Code Info: UDI-DI: 04026575284658 Lot Codes: C010108, C151519
View official government recall

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