LINK SLED Knee System tibial implant recalled for aseptic loosening
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of aseptic loosening and implant wear from improper surgical technique, potentially requiring revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a Class II medical device recall for risk of implant loosening and premature failure requiring revision surgery, but with no reported illnesses or injuries. The hazard meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' yielding a High (3) severity score.
Plain-English summary
Linkbio Corp. is recalling the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP (8 MM X 55 MM, Item Number 15-2230/15) due to risk of aseptic loosening and implant wear. The recall affects 5 units distributed in New York, Nevada, and multiple international locations including 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.
Early aseptic loosening or increased wear of the implant can result from suboptimal positioning or inadequate cementing technique during surgical implantation. These conditions can lead to an unsatisfactory surgical result and potentially require intervention or revision surgery earlier than expected.
Linkbio Corp. is addressing the issue through amendment and reinforcement of the surgical technique and updated product training to ensure proper implant positioning and cementing procedures.
The recalled product
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
- Manufacturer
- Linkbio Corp.
- Affected units
- 5
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: 04026575436750 All lot numbers within the labeled expiration date
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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