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G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

FDA Recall #Z-0493-2014 — Class II — November 26, 2013

Recall #Z-0493-2014 Date: November 26, 2013 Classification: Class II Status: Terminated

Product Description

G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

Reason for Recall

Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.

Recalling Firm

Biomet, Inc. — Warsaw, IN

Classification

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

Product Type

Devices

Product Quantity

532 in USA all under Biomet USA control

Distribution

Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.

Code Information

Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736

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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