FDAClass IINovember 5, 2014

APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna recall

APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.

Why was APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna recalled?

A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.

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?

Part no. A-2791.05, lot no. 14125026

Product
APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
Recalling firm
Medartis, Inc.
Quantity
44
Distribution
US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
Recall date
November 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls