The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1545-2023·Announced 2023-05-10

LINK SLED Knee Implant Surgical Technique Update Required

The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This Class II recall addresses surgical technique training with no reported injuries or hospitalizations. The risk of aseptic loosening and implant wear is conditional on improper surgical technique, making this a precautionary training update.

Plain-English summary

The LINK SLED Knee System (Item 15-2230/04, POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM) is subject to a Class II recall from manufacturer Linkbio Corp. The recall addresses risks 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 improper surgical technique can lead to unsatisfactory surgical results and, in the worst case, require earlier-than-expected revision or intervention surgery. To address this risk, the manufacturer is issuing updated surgical technique guidance and requires future product training on the corrected technique.

Five units of the recalled implant have been distributed to hospitals and surgical centers in New York and Nevada, as well as to multiple international locations including Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, the United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus. Healthcare providers using this implant should consult the updated surgical technique guidance from Linkbio Corp.

The recalled product

Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
Manufacturer
Linkbio Corp.
Category
Medical Device — Knee Implant
Hazard
Affected units
5

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: 04026575429141 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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