The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1515-2023·Announced 2023-05-10

LINK SLED Knee Implant Tibial Component: Surgical Technique Amendment

Linkbio Corp. is issuing updated surgical technique guidance and training for the LINK SLED Knee System tibial component due to risk of early implant loosening or wear from suboptimal positioning or inadequate cementing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a risk-of-harm medical device recall for an orthopedic implant with potential for early aseptic loosening or wear. The source does not report any injuries, hospitalizations, or deaths. The FDA Class II corrective action (surgical technique training and label amendment) supports a High severity rating.

Plain-English summary

The LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item Number 15-2028/05, UDI-DI 04026575043972) is subject to this recall. All lot numbers within the labeled expiration date are included. A total of 19 units were distributed in New York and Nevada in the United States, and internationally to 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 addresses the potential for early aseptic loosening or increased wear of the implant resulting from suboptimal component positioning or inadequate cementing technique during surgery. These factors can lead to unsatisfactory surgical outcomes and, in worst-case scenarios, require earlier-than-expected surgical intervention or implant revision.

The manufacturer has issued amended label warnings and is providing updated surgical technique training to address this issue.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
19

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: 04026575043972 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 →

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