The Recall Desk
HighFDA (Devices)·Z-1549-2023·Announced 2023-05-10

LINK SLED Knee System recalls due to implant loosening risk

Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen prematurely due to improper positioning or cementing technique. Enhanced surgical training is being provided to prevent early device 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 identified risk of early implant loosening requiring potential revision surgery. No reported adverse events or injuries in source text; hazard is recognized but unconfirmed in actual use.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System, a knee replacement component (Item Number 15-2230/10, UDI-DI: 04026575429202). The device may experience early aseptic loosening or increased wear if implanted with suboptimal positioning or inadequate cementing.

The risk may result in unsatisfactory surgical outcomes and the need for unplanned revision or intervention surgery sooner than expected.

Three units have been distributed to healthcare facilities in the United States and internationally, 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.

In response, Linkbio Corp. is updating surgical technique labeling and providing reinforced surgical guidance and training to healthcare providers. Surgeons using this implant should follow the updated surgical technique recommendations.

The recalled product

Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant / Knee Replacement
Hazard
Affected units
3

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: 04026575429202 All lot numbers within 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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