The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1513-2023·Announced 2023-05-10

Knee Implant System Component Recalled Due to Aseptic Loosening Risk

Linkbio Corp. is recalling 13 units of the LINK SLED Knee System tibial component due to risk of aseptic loosening and increased wear. These risks arise from improper surgical positioning or inadequate cementing technique during implantation.

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 FDA Class II recall involves no reported injuries or illnesses. The hazard is early aseptic loosening or increased wear from improper surgical technique, which could require revision surgery. Per the rubric, recalls without reported injuries are scored at most 3.

Plain-English summary

Linkbio Corp. is recalling 13 units of the LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item Number: 15-2028/03). The recalled implants have UDI-DI 04026575043958 and include all lot numbers within the labeled expiration date. The recall affects units distributed to New York and Nevada, as well as international locations including 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 was initiated due to the risk of early aseptic loosening or increased wear of the implant. This risk arises when the implant is positioned suboptimally during surgery or when an inadequate cementing technique is used during the implantation procedure. These factors can lead to an unsatisfactory surgical result and, in the worst case, may require intervention or revision surgery earlier than originally expected.

To address the issue, Linkbio Corp. is amending and reinforcing surgical technique recommendations and providing updated product training to healthcare providers on the correct technique for proper positioning and cementing of the implant. Patients who have received this implant should contact their surgeon for guidance on monitoring their implant and determining whether any follow-up appointments or further evaluation are needed.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Knee Implant
Hazard
Affected units
13

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: 04026575043958 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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