FDAClass IIDecember 12, 2018

Zimmer Smooth Guide Wire - Bullet Tip recall: Sterility Concern

Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used…

Why was Zimmer Smooth Guide Wire - Bullet Tip recalled?

Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility

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 lots expiring prior to September 30, 2023

Product
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used…
Recalling firm
Zimmer Biomet, Inc.
Quantity
48320
Distribution
Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
Recall date
December 12, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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