Knee implant system recall due to aseptic loosening from improper surgical technique
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of early aseptic loosening caused by inadequate surgical technique. Training on improved surgical technique is being provided.
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 recall with risk of premature loosening and wear requiring revision surgery, but no reported injuries. Qualifies as 'risk-of-harm products where injury has not yet been reported' per the rubric, yielding Score 3.
Plain-English summary
Linkbio Corp. is recalling the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM (Item Number: 15-2230/06). Five units of this orthopedic implant component have been distributed in the United States (New York and Nevada) and internationally.
The recall was initiated due to a risk of early aseptic loosening or increased wear of the implant. These complications can result from suboptimal positioning of the implant or inadequate cementing technique during surgery, potentially leading to an unsatisfactory surgical result and the need for intervention or revision surgery earlier than expected.
Linkbio Corp. is providing amendments and reinforcement of surgical technique guidance and will conduct updated product training to address proper implant positioning and cementing procedures.
The recalled product
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-wear
- improper-positioning
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: 04026575429165 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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