Knee implant system recalled due to aseptic loosening and wear risk
Linkbio Corp. is recalling the LINK SLED Knee System due to risk of early aseptic loosening and increased wear caused by improper surgical technique or positioning. The issue 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: This is an FDA Class II recall of a risk-of-harm orthopedic implant where no injuries or hospitalizations have been reported. The hazard is premature implant loosening and wear requiring revision surgery, addressable through updated surgical technique training.
Plain-English summary
Linkbio Corp. is recalling 3 units of the LINK SLED Knee System with POREX ENDO MODEL SLED TIBIAL COMP (Item Number 15-2230/07). The recall addresses a risk of early aseptic loosening and increased wear of the implant, which can occur when the implant is positioned suboptimally or cemented inadequately during surgery.
The issue may lead to an unsatisfactory surgical result and, in the worst case, require intervention or revision surgery earlier than expected.
The FDA has classified this as a Class II recall. Linkbio is updating surgical technique guidance and providing training on the revised implantation technique to prevent these complications. Healthcare providers should review the updated guidance.
The recalled product
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-wear
- surgical-technique-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: 04026575429172 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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