The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1527-2023·Announced 2023-05-10

LINK SLED Knee System Tibial Component Recall for Aseptic Loosening Risk

Linkbio Corp. is recalling the LINK SLED Knee System tibial component due to risk of aseptic loosening and wear. The recall addresses concerns about suboptimal implant positioning or inadequate cementing technique that could lead to early revision surgery.

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 addresses a risk-of-harm orthopedic implant where no injuries or hospitalizations have been reported. It meets High severity criteria as a risk-of-harm product without documented harm.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM (Item Number: 15-2030/02) due to the risk of early aseptic loosening and increased wear of the implant.

The recall addresses concerns that suboptimal positioning of the implant or inadequate cementing technique during surgery can lead to unsatisfactory surgical results and potentially require earlier-than-expected revision or intervention surgery.

The FDA is requiring an amendment and reinforcement of surgical technique guidance and future product training on the updated technique to address these concerns.

Affected patients should consult with their surgeon if they have concerns about their implant. The recall affects 17 units distributed in 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 recalled product

Product
LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant / Knee System
Hazard
Affected units
17

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: 04026575044061 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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