LINK SLED knee implant system surgical technique amendment for aseptic loosening prevention
Linkbio Corp. is updating surgical technique guidance for the LINK SLED knee implant system to prevent early aseptic loosening or implant wear caused by suboptimal positioning or cementing technique 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 a risk-of-harm medical device recall (FDA Class II) where no illnesses or injuries have been reported. The hazard—early aseptic loosening or implant wear—could require surgical revision if proper technique is not followed, meeting the criterion for High severity without reported injuries.
Plain-English summary
The LINK SLED Knee System (POREX ENDO MODEL SLED TIBIAL COMP) manufactured by Linkbio Corp. is subject to amended labeling that reinforces surgical technique and provides updated product training. The amendment addresses a risk of early aseptic loosening or increased wear of the implant that may result from suboptimal positioning of the implant during surgery or inadequate cementing technique.
If the implant is not properly positioned or cemented during surgery, an unsatisfactory surgical result may occur, and patients may require intervention or surgical revision earlier than expected. The updated surgical technique guidance and training materials are intended to ensure proper implant placement and cementing to prevent this complication.
Patients who have received this implant should consult with their surgeon regarding proper postoperative care and activity restrictions. Healthcare providers should review the updated surgical technique guidance and ensure familiarity with proper implant positioning and cementing procedures. The recall applies to 5 units distributed in New York and Nevada, with additional distribution internationally.
The recalled product
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-wear
- inadequate-cementing
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: 04026575429189 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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