FDAClass IIMay 2, 2018

M/DN Intramedullary Fixation Humeral Guide Wire recall

M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00

Why was M/DN Intramedullary Fixation Humeral Guide Wire recalled?

Potential failure of sterile packaging seal.

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?

Lot Numbers: 63733049 63738623 63748399 63753770 63758430 63849380 77006555 77006556 77006557

Product
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
Recalling firm
Zimmer Biomet, Inc.
Quantity
19483 total products
Distribution
US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
Recall date
May 2, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls