Knee implant system amended surgical technique and training guidance
Linkbio Corp. is issuing amended surgical technique guidance for its knee implant system to prevent early loosening and wear caused by improper positioning or inadequate cementing.
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: This is a FDA Class II recall with no reported hospitalizations or injuries. The hazard relates to surgical technique implementation rather than an inherent device defect; Linkbio is addressing it through updated surgical guidance and training.
Plain-English summary
Linkbio Corp. has issued an amendment to the surgical technique and training for the LINK SLED Knee System knee implant (Endo Model Sled Tibial Component 13mm x 45mm, Item 15-2030/04). This action addresses the risk of early aseptic loosening and increased wear of the implant.
The recall was initiated due to observations that suboptimal positioning of the implant or inadequate cementing technique can lead to early aseptic loosening or increased wear, potentially resulting in an unsatisfactory surgical result and the need for earlier-than-expected intervention or revision surgery.
Sixteen units of this implant have been distributed to healthcare facilities in New York, Nevada, and internationally to 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. Linkbio has provided updated surgical technique guidance and implantation procedures. Healthcare providers should review and implement the updated technique to ensure proper implant positioning and cementing.
The recalled product
- Product
- LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04
- Manufacturer
- Linkbio Corp.
- Affected units
- 16
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: 04026575044085 All lot numbers
Distribution
Part of a larger recall action
This product is one of 48 recalled by Linkbio Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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