The Recall Desk
HighFDA (Devices)·Z-1530-2023·Announced 2023-05-10

LINK SLED Knee Implant Recall: Risk of Early Loosening and Revision Surgery

Linkbio Corp. is recalling 14 LINK SLED Knee implants due to risk of aseptic loosening and increased wear caused by improper surgical technique. The implants may fail earlier than expected, requiring 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: FDA Class II medical device recall with risk of aseptic loosening and early implant failure. No reported illnesses, injuries, or deaths are documented in the source; the hazard is theoretical. This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric's Score 3 (High) criterion.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System (ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM, Item Number 15-2030/06). The recall affects 14 units with UDI-DI 04026575044108 and all lot numbers within the labeled expiration date. Distribution includes New York, Nevada, and multiple 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 issued due to risk of early aseptic loosening or increased wear of the implant. These issues can result from suboptimal positioning of the implant or inadequate cementing technique during surgery, leading to unsatisfactory surgical results.

In the worst case, the implant may fail earlier than expected, potentially requiring earlier revision or intervention surgery than originally anticipated. The FDA classified this as a Class II recall. The manufacturer is providing amendments and reinforcement of surgical technique guidelines, along with updated training on the correct surgical method, to address this risk.

The recalled product

Product
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
14

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: 04026575044108 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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