The Recall Desk
HighFDA (Devices)·Z-1525-2023·Announced 2023-05-10

LINK SLED Knee Implant Component Recall for Aseptic Loosening Risk

Linkbio Corp. is recalling the LINK SLED Knee System's all-poly tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing during surgery.

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 with no reported hospitalizations, injuries, or deaths. While early aseptic loosening of knee implants is a clinically significant risk that could necessitate revision surgery, no adverse incidents have been reported, making this a high-risk recall without reported harm.

Plain-English summary

The LINK SLED Knee System All Poly Tibial Component (Item 15-2028/15) is being recalled by Linkbio Corp. This orthopedic implant component was distributed to hospitals and surgical centers in New York and Nevada, as well as internationally, with UDI-DI 04026575359479 in all lot numbers within the labeled expiration date.

The recall was issued because the implant may experience early aseptic loosening or increased wear when not optimally positioned during surgery or not adequately cemented. This can lead to unsatisfactory surgical outcomes and potentially require revision surgery earlier than expected.

Linkbio Corp. is providing reinforced surgical technique guidance and will conduct future product training to address optimal implant positioning and cementing procedures. Healthcare providers should review these updated guidelines to ensure proper implantation technique.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
15

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: 04026575359479 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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