The Recall Desk
HighFDA (Devices)·Z-1508-2023·Announced 2023-05-10

Linkbio LINK SLED Knee implant system recalled for surgical technique requirements

Linkbio Corp. recalls LINK SLED Knee System implants due to risk of early loosening and increased wear caused by improper surgical technique. Updated training and labeling have been issued.

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 recall involving an orthopedic implant at risk of aseptic loosening and wear from surgical technique errors. While no illnesses or injuries have been reported, the potential for early implant failure necessitating revision surgery qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System (ENDO SLED KNEE FEM COMP, MEDIUM SMALL, Item Number: 15-2020/46) implants. Approximately 18 units were distributed to hospital and surgical centers in New York, Nevada, and internationally to Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, the United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus.

The implants are at risk of early aseptic loosening and increased wear when positioned suboptimally or cemented inadequately during surgery. These complications can result in unsatisfactory surgical outcomes and may require revision surgery or additional intervention sooner than expected.

The FDA has classified this as a Class II recall. Linkbio has issued amended labeling and updated surgical technique training to healthcare providers. Surgeons should review the updated surgical guidance and proper cementing procedures before performing procedures with these implants.

The recalled product

Product
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
18

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:04026575209491 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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