Knee implant tibial component recalled for aseptic loosening risk
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risks of early aseptic loosening and implant wear from improper surgical positioning or cementing technique.
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 orthopedic implant recall involving risk of aseptic loosening and implant wear that could necessitate revision surgery. No hospitalizations or injuries have been reported, making this a risk-of-harm product without yet-reported actual harm.
Plain-English summary
Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT (7MM X 45MM, Item Number 15-2028/01) due to risks of early aseptic loosening and increased implant wear.
The recall was initiated because the implant component can loosen or wear prematurely if positioned suboptimally or cemented inadequately during surgery. These issues can lead to unsatisfactory surgical outcomes and may require intervention or revision surgery sooner than expected.
Fourteen units have been distributed to locations in New York and Nevada, as well as internationally to Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, the United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus. All lot numbers within the labeled expiration date are affected.
Linkbio Corp. is reinforcing surgical technique guidance and providing updated product training to address proper implant positioning and cementing technique. Healthcare providers should review the updated surgical guidelines.
The recalled product
- Product
- LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-wear
- surgical-positioning
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: 04026575043934 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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