LINK SLED Knee Implant Component Recall for Aseptic Loosening Risk
Linkbio Corp. is recalling the LINK SLED Knee System's all-poly tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing during 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 medical device recall with no reported hospitalizations, injuries, or deaths. While early aseptic loosening of knee implants is a clinically significant risk that could necessitate revision surgery, no adverse incidents have been reported, making this a high-risk recall without reported harm.
Plain-English summary
The LINK SLED Knee System All Poly Tibial Component (Item 15-2028/15) is being recalled by Linkbio Corp. This orthopedic implant component was distributed to hospitals and surgical centers in New York and Nevada, as well as internationally, with UDI-DI 04026575359479 in all lot numbers within the labeled expiration date.
The recall was issued because the implant may experience early aseptic loosening or increased wear when not optimally positioned during surgery or not adequately cemented. This can lead to unsatisfactory surgical outcomes and potentially require revision surgery earlier than expected.
Linkbio Corp. is providing reinforced surgical technique guidance and will conduct future product training to address optimal implant positioning and cementing procedures. Healthcare providers should review these updated guidelines to ensure proper implantation technique.
The recalled product
- Product
- LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- device-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: 04026575359479 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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