The Recall Desk
HighFDA (Devices)·Z-1518-2023·Announced 2023-05-10

LINK SLED Knee Implant Component Recalled Due to Early Loosening Risk

FDA recalls LINK SLED Knee System tibial components due to risk of aseptic loosening and premature wear. Patients may require 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: This is a Class II recall for a surgical implant component with potential for aseptic loosening and premature wear, which could necessitate revision surgery. No injuries or illnesses have been reported in the source material, consistent with the rubric criterion for 'High' severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

The FDA is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT 13MM X 50MM (Item Number 15-2028/08), manufactured by Linkbio Corp. A total of 24 units were distributed.

The implant components may experience early aseptic loosening or increased wear when improperly positioned during surgery or when cementing technique is inadequate. This can result in an unsatisfactory surgical outcome and may necessitate earlier-than-expected revision surgery.

The recalled components were distributed to facilities in New York and Nevada, as well as to 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. All lot numbers within the labeled expiration date are affected (UDI-DI: 04026575044009).

Surgeons and patients who have received this component should consult with their healthcare provider regarding potential need for revision surgery and appropriate monitoring strategies.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
24

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: 04026575044009 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.

See all →

Same hazard · aseptic loosening

See all →