The Recall Desk
HighFDA (Devices)·Z-1512-2023·Announced 2023-05-10

Knee Implant Recall Due to Risk of Aseptic Loosening and Wear

Linkbio Corp. is recalling 13 units of the LINK SLED knee implant component due to risk of early aseptic loosening or increased wear caused by suboptimal surgical positioning or inadequate cementing technique. Amended surgical technique guidance has been provided.

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 is an FDA Class II medical device recall addressing the risk of implant aseptic loosening and wear due to improper surgical technique. No injuries have been reported. The score reflects a risk-of-harm medical device where injury has not yet been reported, per the severity rubric.

Plain-English summary

Linkbio Corp. is recalling 13 units of the LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item Number: 15-2028/02, UDI-DI: 04026575043941) distributed to New York, Nevada, 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 a risk of early aseptic loosening or increased wear of the implant that can occur if the implant is positioned suboptimally during surgery or if inadequate cementing technique is used. These complications can result in unsatisfactory surgical outcomes and may require earlier-than-expected intervention or surgical revision.

To address this issue, Linkbio Corp. is providing amended surgical technique guidance and reinforcement training on the updated surgical technique for all surgeons and healthcare providers. All lot numbers of the affected component within the labeled expiration date are included in this recall. Healthcare providers should implement the updated surgical technique to minimize the risk of implant loosening or wear.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Knee Implant
Hazard
Affected units
13

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: 04026575043941 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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