The Recall Desk
HighFDA (Devices)·Z-1547-2023·Announced 2023-05-10

Knee implant system recalled due to aseptic loosening and wear risk

Linkbio Corp. is recalling the LINK SLED Knee System due to risk of early aseptic loosening and increased wear caused by improper surgical technique or positioning. The issue may require early revision 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 recall of a risk-of-harm orthopedic implant where no injuries or hospitalizations have been reported. The hazard is premature implant loosening and wear requiring revision surgery, addressable through updated surgical technique training.

Plain-English summary

Linkbio Corp. is recalling 3 units of the LINK SLED Knee System with POREX ENDO MODEL SLED TIBIAL COMP (Item Number 15-2230/07). The recall addresses a risk of early aseptic loosening and increased wear of the implant, which can occur when the implant is positioned suboptimally or cemented inadequately during surgery.

The issue may lead to an unsatisfactory surgical result and, in the worst case, require intervention or revision surgery earlier than expected.

The FDA has classified this as a Class II recall. Linkbio is updating surgical technique guidance and providing training on the revised implantation technique to prevent these complications. Healthcare providers should review the updated guidance.

The recalled product

Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic implant
Hazard
Affected units
3

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: 04026575429172 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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