Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) Due to A crack in the weld of the rasp...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Waldemar Link GmbH & Co. KG (Mfg Site) directly.
Affected Products
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
Quantity: 6 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 3 states: GA, IN, TX
About Waldemar Link GmbH & Co. KG (Mfg Site)
Waldemar Link GmbH & Co. KG (Mfg Site) has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report