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
Reported: September 6, 2023 Initiated: July 26, 2023 #Z-2481-2023
Product Description
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
Details
- Recalling Firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Units Affected
- 6 units
- Distribution
- IN,GA, TX
- Location
- Norderstedt, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Waldemar Link GmbH & Co. KG (Mfg Site). Units affected: 6 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2481-2023.
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