LINK SLED Knee System Tibial Implant Aseptic Loosening Risk
The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.
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: FDA Class II recall with no reported illnesses or injuries. The risk is conditional on improper surgical technique rather than a manufacturing defect. The corrective action is training and technique reinforcement, consistent with a voluntary precautionary recall.
Plain-English summary
The LINK SLED Knee System tibial component (8 mm × 50 mm) is subject to a Class II notification due to risk of early aseptic loosening or increased wear if the implant is not positioned or cemented properly during surgery. Affected implants include 14 units distributed to facilities in New York, Nevada, and multiple international locations (UDI-DI: 04026575436712).
Improper surgical positioning or inadequate cementing technique can lead to implant failure, unsatisfactory surgical outcomes, and potential need for revision surgery earlier than expected. Linkbio Corp. is issuing this notice to prevent these complications.
In response, Linkbio is providing amended label warnings, reinforcement of surgical technique, and updated product training for surgeons and surgical teams. Facilities and surgeons using this implant should review the updated technique guidelines and implement proper positioning and cementing procedures before performing surgery. The notification applies to all lot numbers within the labeled expiration date.
The recalled product
- Product
- LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14
- 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: 04026575436712 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27