LINK SLED Knee Implant Recall for Aseptic Loosening Risk
The LINK SLED Knee System POREX ENDO tibial implant is recalled due to risk of early aseptic loosening or increased wear from suboptimal positioning or inadequate cementing. Affected patients may require early revision 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 recall with no reported hospitalizations or illnesses. The hazard—premature implant loosening and wear—represents a risk-of-harm without reported patient injury, placing this at Score 3 per the rubric criterion for risk-based medical device recalls.
Plain-English summary
The LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP (11 MM X 55 MM, Item Number 15-2230/11) is recalled by Linkbio Corp. Three units were distributed to hospitals in New York and Nevada, with additional international distribution.
The implant poses a risk of early aseptic loosening or increased wear if positioned suboptimally during surgery or if cementing technique is inadequate. This can lead to an unsatisfactory surgical result and, in worst-case scenarios, may require early revision surgery.
The FDA is requiring amended product labeling and updated surgical technique training from the manufacturer. Healthcare providers should ensure proper implant positioning and appropriate cementing technique during surgery. Patients with this implant should contact their healthcare provider with any concerns.
The recalled product
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-wear
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: 04026575429219 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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