The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1543-2023·Announced 2023-05-10

LINK SLED Knee System Tibial Component Recall Due to Surgical Technique Issues

Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening or premature wear caused by suboptimal implant positioning or inadequate cementing during surgery. The manufacturer is updating surgical technique guidance and training.

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 3/5 (High).

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 product (orthopedic implant with potential for early failure requiring revision surgery). No hospitalizations or injuries are reported in the source text, placing it at the high end of risk-of-harm without actual reported harm per the rubric.

Plain-English summary

Linkbio Corp. is recalling LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP (9 MM X 45 MM, Item Number: 15-2230/02). Five units were distributed in New York and Nevada, as well as internationally in 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 the risk of early aseptic loosening or increased wear of the implant. The manufacturer identified that suboptimal positioning of the implant or inadequate cementing technique during surgery can lead to these complications, resulting in unsatisfactory surgical outcomes. In the worst case, implant loosening or wear may necessitate earlier-than-expected surgical intervention or revision.

Linkbio Corp. is addressing this issue by providing amended label warnings and reinforced surgical technique guidance, along with updated training for surgical teams. Healthcare providers implanting this device should follow the updated surgical technique recommendations to prevent implant loosening or premature wear.

The recalled product

Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic 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: 04026575429127 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 →

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