The Recall Desk
HighFDA (Devices)·Z-1539-2023·Announced 2023-05-10

Orthopedic knee implant system recalled due to early loosening risk

Linkbio Corp. is recalling 5 units of the LINK SLED Knee System due to risk of early aseptic loosening or increased wear that could require earlier surgical revision. The recall addresses training and surgical technique to prevent implant failure.

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 a Class II medical device recall addressing a risk-of-harm product (orthopedic implant with potential for early failure and revision surgery). No illnesses or injuries have been reported, consistent with the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Linkbio Corp. is recalling 5 units of the LINK SLED Knee System, specifically the POREX ENDO SLED KNEE FEM COMP, SMALL (Item Number 15-2220/40). This is an orthopedic implant intended for knee replacement surgery.

The recall was initiated due to a risk of early aseptic loosening or increased wear of the implant. These problems can occur if the implant is positioned suboptimally during surgery or if cementing techniques are inadequate. In the worst case, this could lead to an unsatisfactory surgical result requiring intervention or revision surgery sooner than expected.

The affected devices have been distributed to healthcare facilities in New York, Nevada, and internationally in 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. All lot numbers within the expiration date are included in this recall (UDI-DI: 04026575429073).

Healthcare providers who have received these devices should implement the manufacturer's updated surgical techniques and training. Patients who have received this implant should consult with their healthcare provider if they have concerns about their implant's stability or function.

The recalled product

Product
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
5

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: 04026575429073 All lot numbers within 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.

See all →

Same hazard · aseptic loosening

See all →