Knee Implant Component Recalled for Surgical Positioning and Cementing Guidance
FDA is updating surgical instructions for the LINK SLED Knee System to address early aseptic loosening and increased wear from suboptimal positioning or inadequate cementing technique. Updated training aims to prevent implant failure and unexpected revision 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 meets the 'High' severity criterion: it is a risk-of-harm product (surgical implant with potential aseptic loosening and wear) where injury has not been reported. No hospitalizations or deaths are mentioned in the recall announcement.
Plain-English summary
The LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP (Item Number: 15-2230/03) is being recalled by Linkbio Corp. due to early aseptic loosening and increased wear of the implant caused by suboptimal positioning during surgery or inadequate cementing technique.
The FDA has classified this as a Class II recall. If not properly positioned and cemented, the implant can experience early failure, leading to unsatisfactory surgical results and potentially requiring unexpected intervention or revision surgery sooner than expected.
Linkbio Corp. is providing amended surgical technique guidelines and reinforced training on proper positioning and cementing techniques. Surgeons and surgical teams using this implant component should review and implement the updated guidance to ensure proper implant positioning and cementing.
Five units of the affected implant component were distributed in the United States (New York and Nevada) and internationally (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). All lot numbers within the labeled expiration date are included in this recall.
The recalled product
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
- Manufacturer
- Linkbio Corp.
- Category
- Medical Device — Knee Implant
- Hazard
- aseptic-loosening
- implant-wear
- revision-risk
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: 04026575429134 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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