FDAClass IIJuly 5, 2023

LINK Endo-Model Modular Knee Prosthesis System Femoral recall

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left

Why was LINK Endo-Model Modular Knee Prosthesis System Femoral recalled?

The firm discovered through customer complaints that device segments may not meet specifications.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item No. 15/2973/06; UDI-DI: 04026575340736.

Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
22 units
Distribution
Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
Recall date
July 5, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls