Reported Sep 6, 2023 · Ongoing
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis…
Waldemar Link GmbH & Co. KG (Mfg Site)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Waldemar Link GmbH & Co. KG (Mfg Site) · Oststr. 4-10 · Norderstedt, N/A · N/A
Is this the product you have?
- 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 Number17-5220/01
- Lot codes and dates
- UDI-DI04026575284658
- Lot Codes
C010108C151519
- Amount recalled
- 6 units
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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