Linkbio Knee Implant Recalled for Aseptic Loosening Risk
Linkbio Corp. is recalling 15 LINK SLED Knee System implants due to risk of aseptic loosening and wear from improper surgical technique. The company is providing amended surgical guidance and training to prevent implant 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 a known risk of aseptic loosening and implant failure. No illnesses, injuries, or deaths have been reported. Per the rubric, this qualifies as High (score 3): a risk-of-harm medical device where injury has not yet been reported.
Plain-English summary
Linkbio Corp. is recalling 15 units of the LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item Number 15-2028/11). The product was distributed in New York, Nevada, and multiple international locations including Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, the United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus.
The recall addresses a risk of early aseptic loosening or increased wear of the knee implant caused by suboptimal implant positioning or inadequate cementing technique during surgery. These issues can lead to unsatisfactory surgical results and, in the worst case, may require earlier-than-expected revision surgery.
The remedy consists of amendments to surgical technique guidance and training on updated techniques to prevent improper implantation and cementing.
The recalled product
- Product
- LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
- Manufacturer
- Linkbio Corp.
- Hazard
- aseptic-loosening
- implant-failure
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: 04026575044030 All lot numbers within the labeled expiration date
Distribution
Distributed in 2 states:
- NV
- NY
Related recalls
Same category
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- SevereDexcom G7 Continuous Glucose Monitoring System sensors recalled
FDA (Devices) · 2026-07-01