FDAClass IIJuly 31, 2024

LINK SymphoKnee Patella Sizing Template recall

LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

Why was LINK SymphoKnee Patella Sizing Template recalled?

The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.

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 Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.

Product
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Recalling firm
LINK BIO CORP
Quantity
8 units
Distribution
US Nationwide distribution in the states of FL, GA, KS, OH, WI.
Recall date
July 31, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls