The Recall Desk
HighFDA (Devices)·Z-1540-2023·Announced 2023-05-10

LINK SLED Knee System recalls issued over aseptic loosening risk

Linkbio Corp. is recalling LINK SLED Knee System knee components due to risk of early aseptic loosening or increased wear. The company is issuing updated surgical technique guidance to address suboptimal implant positioning and cementing techniques.

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 recall addressing risk of aseptic loosening and implant wear potentially requiring early revision surgery. No reported illnesses, injuries, or deaths are documented, making this a risk-of-harm scenario where injury has not yet been reported, which per the severity rubric warrants a score of 3.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System component (POREX ENDO SLED KNEE FEM COMP, medium small, Item Number 15-2220/46). The recall affects 4 units distributed in New York, Nevada, and internationally.

The company identified a risk of early aseptic loosening or increased wear of the implant. These complications can result from suboptimal positioning of the implant during surgery or inadequate cementing technique. The potential consequence is an unsatisfactory surgical result and possible need for intervention or revision surgery earlier than originally expected.

To address this issue, Linkbio Corp. is providing amended and reinforced guidance on proper surgical technique, along with updated training. All product lot numbers within the expiration date remain subject to this guidance update.

Healthcare providers who have used or received this implant should ensure they have reviewed the updated surgical technique guidance from Linkbio Corp.

The recalled product

Product
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
4

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: 04026575429080 All lot numbers within 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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