Knee implant recalled due to early aseptic loosening risk from surgical technique
LINK SLED Knee System tibial components are being recalled due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Surgical technique guidance is being issued.
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 with identified risk of early aseptic loosening and potential implant failure requiring revision surgery. No illnesses or injuries have been reported to date, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item Number 15-2028/04, UDI-DI: 04026575043965). The recall affects 14 units that were distributed in the United States (New York and Nevada) and internationally in 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 U.S. Food and Drug Administration classified this as a Class II recall. The company identified a risk that early aseptic loosening or increased wear may occur if the implant is positioned suboptimally during surgery or if cementing technique is inadequate. In the worst case, this could result in unsatisfactory surgical outcomes and may require revision surgery earlier than expected.
In response, Linkbio Corp. is issuing an amendment and reinforcement of surgical technique guidance and providing updated product training. This guidance addresses proper implant positioning and cementing procedures to prevent the identified risk.
The recalled product
- Product
- LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
- Manufacturer
- Linkbio Corp.
- Category
- Medical Device — Knee Implant
- Hazard
- aseptic-loosening
- implant-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: 04026575043965 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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