FDAClass IIFebruary 7, 2018

Equinoxe Cage recall: Labeling Error

Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with…

Why was Equinoxe Cage recalled?

Potentially mislabeled.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Catalog #: 314-13-03 Serial Range: 5013020 - 5013049

Product
Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with…
Recalling firm
Exactech, Inc.
Quantity
30
Distribution
Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
Recall date
February 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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