The Recall Desk
HighFDA (Devices)·Z-1522-2023·Announced 2023-05-10

Knee Implant Component Recalled for Aseptic Loosening Risk

Linkbio Corp. recalls 14 units of the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Healthcare providers should follow updated surgical guidance.

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: This is an FDA Class II recall without reported hospitalizations or injuries. The hazard involves risk of early aseptic loosening requiring potential surgical revision, which qualifies as a risk-of-harm product per the rubric. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item Number 15-2028/12, 13MM x 55MM). A total of 14 units were distributed to patients in New York and Nevada, as well as to 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.

The recall is due to early aseptic loosening or increased wear of the implant component. This condition can result from suboptimal positioning of the implant during surgery or inadequate cementing technique during implantation, which may lead to unsatisfactory surgical results.

In the worst-case scenario, patients may require intervention or surgical revision earlier than originally expected. To address this issue, the FDA has required Linkbio Corp. to provide amended label warnings and reinforce updated surgical techniques through enhanced product training.

Patients with this implant and their healthcare providers should refer to the updated surgical technique guidance and training provided by Linkbio Corp. to ensure proper implant positioning and cementing technique in any future procedures.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
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: 04026575044047 All lot numbers within the labeled expiration date

Distribution

Distributed in 2 states:

  • NV
  • NY

Related recalls

Same category