LINK SLED Knee System Recalled for Aseptic Loosening and Implant Wear
Linkbio Corp. is recalling 12 units of the LINK SLED Knee System due to risk of implant loosening and wear that could require revision surgery sooner than expected.
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 medical device recall with no reported illnesses, injuries, or hospitalizations. The hazard involves a high-risk orthopedic implant with potential for requiring revision surgery, but injury has not yet been reported, placing it in the 'High' severity category per the rubric.
Plain-English summary
Linkbio Corp. is recalling the LINK SLED Knee System (Item Number 15-2030/10), an orthopedic knee implant. A total of 12 units were distributed to the United States (New York and 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.
The recall is due to a risk of early aseptic loosening and increased implant wear. According to the FDA, these problems can result from suboptimal positioning of the implant during surgery or inadequate cementing technique. When these conditions occur, the implant may become unstable, leading to an unsatisfactory surgical result and potentially requiring revision surgery sooner than expected.
Healthcare providers should verify their inventory against the UDI-DI 04026575044146 and check all lot numbers within the labeled expiration date. Linkbio Corp. is issuing amended surgical technique guidance and will provide updated product training on proper implantation methods to prevent this complication.
The recalled product
- Product
- LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10
- 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: 04026575044146 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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