Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP Recalled by Linkbio Corp. Due to Additional Label Warnings: Amendment / reinforcement of the...

Date: March 21, 2023
Company: Linkbio Corp.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Linkbio Corp. directly.

Affected Products

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08

Quantity: 5 units

Why Was This Recalled?

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

Where Was This Sold?

This product was distributed to 2 states: NV, NY

Affected (2 states)Not affected

About Linkbio Corp.

Linkbio Corp. has 49 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report