The Recall Desk
HighFDA (Devices)·Z-1532-2023·Announced 2023-05-10

LINK SLED Knee System Tibial Component Recall Due to Early Loosening Risk

Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening and increased wear from improper implant positioning or inadequate cementing. Patients may require revision surgery earlier than expected.

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 recall addresses a documented risk of implant failure (early aseptic loosening and wear) that may necessitate revision surgery, meeting the criterion for high-risk products where injury has not yet been reported. No patient illnesses or deaths have been documented in the source.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM (Item Number 15-2030/08, UDI-DI: 04026575044122) due to risk of early aseptic loosening and increased wear. The recall covers all units within the labeled expiration date, with 20 units distributed in New York, Nevada, and multiple 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 FDA determined that early aseptic loosening and increased implant wear can result from suboptimal implant positioning or inadequate cementing technique during surgical placement. These complications can lead to unsatisfactory surgical outcomes.

Patients may require revision surgery earlier than expected. Linkbio Corp. is issuing amended surgical technique guidance and updated training materials to healthcare providers on proper implant positioning and cementing methods.

Patients who have received this implant should contact their surgeon if they experience complications or concerns about implant stability or performance.

The recalled product

Product
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
20

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: 04026575044122 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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