LINK SLED Knee Prosthesis Recalled for Risk of Premature Failure
Linkbio Corp. is recalling LINK SLED Knee System prostheses due to risk of early aseptic loosening or increased wear caused by suboptimal surgical technique. The company is providing amended surgical guidelines and training.
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 device with risk of premature implant failure potentially requiring revision surgery. No injuries or hospitalizations reported; classified as high-risk based on potential for harm without documented incidents.
Plain-English summary
Linkbio Corp. is recalling the LINK SLED Knee System, specifically the ENDO SLED KNEE FEM COMP, MEDIUM (Item Number 15-2020/52), a knee prosthesis. Seventeen units were distributed to locations in the United States and multiple countries worldwide.
The recall was initiated due to the risk of early aseptic loosening or increased wear of the implant caused by suboptimal surgical positioning or inadequate cementing technique. These issues can lead to an unsatisfactory surgical result and, in the worst case, require revision surgery or additional intervention sooner than typically expected.
Linkbio Corp. is addressing the issue by providing amended surgical technique guidelines and training to healthcare providers on the updated surgical approach. The recall applies to all lot numbers within the labeled expiration date (UDI-DI: 04026575043903).
The recalled product
- Product
- LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- excessive-wear
- cementation-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: 04026575043903 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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