Knee Implant System Warning: Risk of Early Loosening Due to Surgical Technique
Linkbio Corp. is updating labeling and surgical technique training for the LINK SLED Knee System to prevent early aseptic loosening or excessive wear caused by improper implant positioning or inadequate cementing during surgery.
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 implant failure and early revision surgery if proper surgical technique is not used. No illnesses or hospitalizations have been reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Linkbio Corp. is issuing a safety update for the LINK SLED Knee System (Item Number 15-2230/14, UDI-DI 04026575436743), a surgical knee implant used in orthopedic procedures. The update addresses early aseptic loosening or increased wear of the implant that can occur when the implant is positioned suboptimally or cemented inadequately during surgery.
The company is amending product labeling and providing reinforced surgical technique training to healthcare providers. Correct implant positioning and cementing technique are essential to preventing unsatisfactory surgical results and avoiding the need for early intervention or revision surgery.
The affected implant has been distributed to patients in New York, Nevada, and 21 countries including Bulgaria, France, Germany, United Kingdom, Italy, Spain, Austria, and others. Healthcare providers and patients who received this implant should ensure that the updated surgical technique guidance is reviewed and followed. Patients with concerns about their knee implant should contact their surgeon.
The recalled product
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
- 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: 04026575436743 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
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