FDAClass IIFebruary 21, 2018

Exactech GPS Total Shoulder Application 3.2mm Vix Bit recall

Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

Why was Exactech GPS Total Shoulder Application 3.2mm Vix Bit recalled?

Vix Bit may fracture during use.

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 No. 531-15-08, Lot No. 75296003, 80129003, 81327001

Product
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Recalling firm
Exactech, Inc.
Quantity
41 devices
Distribution
Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
Recall date
February 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls