The Recall Desk
HighFDA (Devices)·Z-1536-2023·Announced 2023-05-10

Knee Implant System Recalled for Premature Loosening and Wear Risk

Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen or wear prematurely due to improper surgical positioning or cementing, potentially requiring revision surgery. Updated surgical technique guidance is being provided.

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: This is an FDA Class II medical device recall involving surgical implants that can prematurely loosen or wear, potentially requiring revision surgery. No reported injuries or adverse events are documented in the source material, but the risk to patient safety from premature implant failure is significant.

Plain-English summary

Linkbio Corp. is recalling LINK SLED Knee System implants (Item Number 15-2030/13). The recall involves 13 units with UDI-DI 04026575436705 and all lot numbers within the labeled expiration date.

The implants may experience early aseptic loosening or increased wear due to suboptimal implant positioning or inadequate cementing technique during surgical implantation. These issues can result in unsatisfactory surgical outcomes and, in the worst case, require earlier-than-expected revision surgery.

Affected units were distributed to New York and Nevada in the United States, and to 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.

Linkbio Corp. is amending labeling with reinforced surgical technique warnings and updated technique guidance. All healthcare facilities and surgeons using this implant system should review and implement the updated surgical technique to ensure proper implant positioning and cementing.

The recalled product

Product
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13
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: 04026575436705 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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