FDAClass IIFebruary 14, 2018

Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm recall

Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used…

Why was Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm recalled?

The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.

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?

All Lot Numbers Expiry Date Before April 2022

Product
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used…
Recalling firm
Zimmer Biomet, Inc.
Quantity
7,888 units
Distribution
Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
Recall date
February 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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