Surgical Rasp Handle May Fracture Due to Weld Crack
The Link OptiStem Rasp Handle used in knee replacement surgery may develop a crack in the weld that causes the handle to fracture. If this occurs, surgical removal of the rasp must be modified, potentially prolonging the procedure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical instrument with a structural defect (weld crack leading to handle fracture). While no injuries have been reported, the defect poses a risk-of-harm product where surgical complications including prolonged operative time and modified surgical technique are possible.
Plain-English summary
The Link OptiStem Rasp Handle (Item Number 17-5220/01) is a surgical instrument used during total knee arthroplasty to prepare the femoral medullary canal for implantation of a knee prosthesis. The handle may develop a crack in its weld, which can lead to fracture of the frontal sleeve when the rasp is impacted or extracted during surgery.
If the handle fractures, the rasp instrument itself remains intact, but the broken handle must be removed using a clamp or alternative technique. This complication can result in prolongation of the surgical procedure or modification of the surgical approach.
The FDA Class II recall affects 6 units distributed to healthcare facilities in Indiana, Georgia, and Texas. Affected units can be identified by lot codes C010108 and C151519 (UDI-DI: 04026575284658). Healthcare providers should contact Waldemar Link GmbH & Co. KG or the FDA for guidance on affected instruments and recommended action.
The recalled product
- 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
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 04026575284658 Lot Codes: C010108
- C151519
Distribution
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