Knee implant system recalled due to risk of aseptic loosening
The LINK SLED Knee System has been recalled due to risk of early aseptic loosening and wear caused by suboptimal implant positioning or inadequate cementing technique during surgery.
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 medical device without reported illnesses or injuries. The hazard—early aseptic loosening and wear potentially requiring revision surgery—is serious if it occurs but currently theoretical, fitting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
The LINK SLED Knee System (Item Number 15-2030/11), manufactured by Linkbio Corp., has been recalled due to risk of early aseptic loosening and increased wear. All lot numbers within the labeled expiration date are affected.
The risk arises from suboptimal implant positioning or inadequate cementing technique during surgical implantation. These procedural issues can result in unsatisfactory surgical outcomes and, in worst-case scenarios, may necessitate earlier-than-expected revision or intervention surgery.
The recall involves 20 units distributed to New York and Nevada, as well as Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus.
The manufacturer is issuing amended surgical technique guidance and will provide updated product training to surgeons. Proper implant positioning and cementing technique are essential to prevent aseptic loosening and ensure optimal long-term implant performance.
The recalled product
- Product
- LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-wear
- device-failure
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 (1)
- UDI-DI: 04026575044153 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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