FDAClass IIJuly 19, 2017

Exactech Optetrak Logic CC 15mm Tibial Augment Screws recall

Exactech Optetrak Logic CC 15mm Tibial Augment Screws

Why was Exactech Optetrak Logic CC 15mm Tibial Augment Screws recalled?

Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.

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. 02-012-50-9015; Serial #'s 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538.

Product
Exactech Optetrak Logic CC 15mm Tibial Augment Screws
Recalling firm
Exactech, Inc.
Quantity
9 devices
Distribution
CA and NY.
Recall date
July 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls