LINK SLED Knee Implant Tibial Component: Surgical Technique Amendment
Linkbio Corp. is issuing updated surgical technique guidance and training for the LINK SLED Knee System tibial component due to risk of early implant loosening or wear from suboptimal positioning or inadequate cementing.
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 a risk-of-harm medical device recall for an orthopedic implant with potential for early aseptic loosening or wear. The source does not report any injuries, hospitalizations, or deaths. The FDA Class II corrective action (surgical technique training and label amendment) supports a High severity rating.
Plain-English summary
The LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item Number 15-2028/05, UDI-DI 04026575043972) is subject to this recall. All lot numbers within the labeled expiration date are included. A total of 19 units were distributed in New York and Nevada in the United States, and internationally to 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 recall addresses the potential for early aseptic loosening or increased wear of the implant resulting from suboptimal component positioning or inadequate cementing technique during surgery. These factors can lead to unsatisfactory surgical outcomes and, in worst-case scenarios, require earlier-than-expected surgical intervention or implant revision.
The manufacturer has issued amended label warnings and is providing updated surgical technique training to address this issue.
The recalled product
- Product
- LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-wear
- surgical-technique
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: 04026575043972 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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