Knee implant component recalled for risk of premature loosening and wear
Linkbio Corp. is recalling 14 units of LINK SLED Knee System knee implant components due to risk of early loosening and wear caused by suboptimal implant positioning or inadequate cementing technique. Affected patients should contact their surgeon.
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 is an FDA Class II device recall with a documented risk of premature implant failure requiring revision surgery. The source material contains no reports of actual illnesses or injuries. This meets the criteria for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The recall affects the LINK SLED Knee System ENDO SLED KNEE FEM COMP, SMALL (Item Number 15-2020/40), manufactured by Linkbio Corp. A total of 14 units have been identified. The affected components have a UDI-DI of 04026575043897 and include all lot numbers within the labeled expiration date.
The recall has been issued due to the risk of early aseptic loosening or increased wear of the implant. These complications can occur when the implant is positioned suboptimally or when the cementing technique is inadequate during surgery. In such cases, patients may require intervention or revision surgery earlier than expected.
The recalled units have been distributed to patients in New York and Nevada in the United States, as well as internationally to Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, the United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus.
Linkbio Corp. has issued an amendment and reinforcement to surgical technique guidance and will provide updated product training to prevent these complications. Patients who have received this implant should consult with their healthcare provider or surgeon to discuss their individual situation and any necessary monitoring or follow-up care.
The recalled product
- Product
- LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
- Manufacturer
- Linkbio Corp.
- 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: 04026575043897 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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