LINK SLED knee implant system recalled for inadequate surgical technique
Linkbio Corp. is amending training for the LINK SLED Knee System due to early implant loosening and wear caused by inadequate surgical positioning and cementing techniques. Healthcare providers should implement updated surgical guidance.
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 medical device with potential for serious harm (early implant loosening requiring revision surgery), but no reported injuries or illnesses mentioned in the source. Per the rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
The LINK SLED Knee System (Item Number 15-2020/60) manufactured by Linkbio Corp. is subject to a recall involving amendments to surgical technique guidance and updated training materials.
The original surgical technique guidance was inadequate, potentially leading to suboptimal positioning or inadequate cementing of the implant during surgery. This can result in early aseptic loosening or increased wear of the implant, causing unsatisfactory surgical outcomes and potentially requiring revision surgery sooner than expected.
The recall affects 12 units distributed to New York and Nevada in the United States, with additional distribution to 24 countries including Bulgaria, France, Germany, Italy, the United Kingdom, Australia, China, India, Mexico, and others. Healthcare facilities and surgical teams should implement the amended surgical technique guidance and participate in updated product training to ensure proper implant positioning and cementing.
The recalled product
- Product
- LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
- Manufacturer
- Linkbio Corp.
- Category
- Medical Device — Knee Implant
- Hazard
- aseptic-loosening
- implant-wear
- surgical-technique
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: 04026575043910 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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