LINK SLED Knee System recalls due to implant loosening risk
Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen prematurely due to improper positioning or cementing technique. Enhanced surgical training is being provided to prevent early device failure.
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 with identified risk of early implant loosening requiring potential revision surgery. No reported adverse events or injuries in source text; hazard is recognized but unconfirmed in actual use.
Plain-English summary
Linkbio Corp. is recalling the LINK SLED Knee System, a knee replacement component (Item Number 15-2230/10, UDI-DI: 04026575429202). The device may experience early aseptic loosening or increased wear if implanted with suboptimal positioning or inadequate cementing.
The risk may result in unsatisfactory surgical outcomes and the need for unplanned revision or intervention surgery sooner than expected.
Three units have been distributed to healthcare facilities in the United States and internationally, 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.
In response, Linkbio Corp. is updating surgical technique labeling and providing reinforced surgical guidance and training to healthcare providers. Surgeons using this implant should follow the updated surgical technique recommendations.
The recalled product
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
- 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: 04026575429202 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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