The Recall Desk
HighFDA (Devices)·Z-1542-2023·Announced 2023-05-10

Knee Implant System Recalled for Risk of Aseptic Loosening

Linkbio Corp. recalls the LINK SLED Knee System due to risk of aseptic loosening from improper positioning or cementing technique, potentially requiring revision surgery. Five units affected in US and international distribution.

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 recall of surgical knee implant with risk of aseptic loosening and premature implant wear potentially requiring revision surgery. No hospitalizations or injuries currently reported, classifying it as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System, a surgical knee implant (Item Number 15-2220/60). Five units have been distributed to New York and Nevada in the United States, and to numerous countries 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 is due to the risk of early aseptic loosening or increased wear of the implant caused by suboptimal positioning or inadequate cementing technique during surgery. These issues can result in an unsatisfactory surgical outcome and, in severe cases, may require intervention or revision surgery sooner than expected.

Linkbio Corp. is amending surgical technique guidance and providing updated product training to address the causes of early implant loosening and wear. Surgeons who have implanted this device or patients who have received this implant should consult their healthcare provider if they have concerns about the implant.

The recalled product

Product
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
5

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: 04026575429103 All lot numbers the labeled expiration date

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 48 recalled by Linkbio Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 48 products in this recall →

Related recalls

Same manufacturer · Linkbio Corp.

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Same hazard · aseptic loosening

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