The Recall Desk
HighFDA (Devices)·Z-1524-2023·Announced 2023-05-10

LINK SLED Knee System tibial component subject to early loosening recall

Linkbio Corp. is recalling the LINK SLED Knee System tibial component (15 units) due to risk of early loosening and increased wear from inadequate surgical technique, potentially requiring earlier-than-expected revision 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: This Class II FDA recall involves an orthopedic implant with risk of structural failure (early aseptic loosening and increased wear) that could necessitate premature revision surgery. No illnesses or injuries are reported in the source text, placing this in the category of risk-of-harm products where injury has not yet been reported, warranting a High severity rating.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System tibial component (Item Number 15-2028/14) due to risk of early implant failure. The recall affects 15 units distributed in the United States (New York and Nevada) and internationally (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). All lot numbers within the labeled expiration date are affected (UDI-DI: 04026575359462).

The implant is subject to early aseptic loosening or increased wear when positioned suboptimally or when inadequate cementing technique is used during implantation. This can result in an unsatisfactory surgical outcome and may require intervention or revision surgery earlier than the implant's expected lifespan.

The manufacturer is amending its surgical technique guidance and providing updated product training to address proper implant positioning and cementing procedures. Surgeons and patients with this implant should review the updated surgical instructions provided by Linkbio Corp.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
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: 04026575359462 All lot numbers within the labeled expiration date

Distribution

Distributed in 2 states:

  • NV
  • NY

Related recalls

Same category