LINK SLED Knee System tibial component recall for aseptic loosening and wear risk
Linkbio Corp. is recalling 15 units of the LINK SLED Knee System tibial component for risk of aseptic loosening and wear from improper implant positioning or inadequate cementing technique. Surgical training will be updated.
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 recall for structural implant defect (aseptic loosening and wear) with potential for patient harm requiring revision surgery. No reported injuries or hospitalizations are explicitly stated in the source, limiting severity to High per the rubric.
Plain-English summary
Linkbio Corp. is recalling 15 units of the LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP (Item Number 15-2030/03) distributed in New York, Nevada, and multiple countries worldwide.
The recall addresses a risk of early aseptic loosening or increased wear of the implant. This risk arises from suboptimal positioning of the implant during surgery or inadequate cementing technique. Both can lead to unsatisfactory surgical results and may require intervention or revision surgery earlier than expected.
In response, Linkbio Corp. is issuing amendments to surgical technique guidelines and conducting updated product training to reinforce proper implant positioning and cementing procedures.
Patients who received this implant should contact their healthcare provider to discuss their individual risk. Healthcare providers using this product should review the updated surgical technique guidance.
The recalled product
- Product
- LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-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: 04026575044078 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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