LINK SLED Knee System Tibial Component Recall Due to Early Loosening Risk
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening and increased wear from improper implant positioning or inadequate cementing. Patients may require revision surgery earlier than expected.
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 Class II recall addresses a documented risk of implant failure (early aseptic loosening and wear) that may necessitate revision surgery, meeting the criterion for high-risk products where injury has not yet been reported. No patient illnesses or deaths have been documented in the source.
Plain-English summary
Linkbio Corp. is recalling the LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM (Item Number 15-2030/08, UDI-DI: 04026575044122) due to risk of early aseptic loosening and increased wear. The recall covers all units within the labeled expiration date, with 20 units distributed in New York, Nevada, and multiple international locations including 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 FDA determined that early aseptic loosening and increased implant wear can result from suboptimal implant positioning or inadequate cementing technique during surgical placement. These complications can lead to unsatisfactory surgical outcomes.
Patients may require revision surgery earlier than expected. Linkbio Corp. is issuing amended surgical technique guidance and updated training materials to healthcare providers on proper implant positioning and cementing methods.
Patients who have received this implant should contact their surgeon if they experience complications or concerns about implant stability or performance.
The recalled product
- Product
- LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-wear
- surgical-technique-defect
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: 04026575044122 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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