LINK SLED Knee Implant Surgical Technique Update Required
The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II recall addresses surgical technique training with no reported injuries or hospitalizations. The risk of aseptic loosening and implant wear is conditional on improper surgical technique, making this a precautionary training update.
Plain-English summary
The LINK SLED Knee System (Item 15-2230/04, POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM) is subject to a Class II recall from manufacturer Linkbio Corp. The recall addresses risks 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 improper surgical technique can lead to unsatisfactory surgical results and, in the worst case, require earlier-than-expected revision or intervention surgery. To address this risk, the manufacturer is issuing updated surgical technique guidance and requires future product training on the corrected technique.
Five units of the recalled implant have been distributed to hospitals and surgical centers in New York and Nevada, as well as to multiple international locations including Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, the United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus. Healthcare providers using this implant should consult the updated surgical technique guidance from Linkbio Corp.
The recalled product
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
- Manufacturer
- Linkbio Corp.
- Category
- Medical Device — Knee Implant
- Hazard
- aseptic-loosening
- implant-wear
- surgical-technique-issue
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: 04026575429141 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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