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Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in kne...

FDA Recall #Z-0723-2021 — Class II — December 1, 2020

Recall #Z-0723-2021 Date: December 1, 2020 Classification: Class II Status: Terminated

Product Description

Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422

Reason for Recall

Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

Recalling Firm

Biomet, Inc. — Warsaw, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

21 units

Distribution

Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.

Code Information

Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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