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Recall Observatory FDA recall evidence

Device product

G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

Z-0493-2014

November 26, 2013

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 66967
Status
Terminated
Classification
Class II
Quantity
532 in USA all under Biomet USA control
Official record key
device-enforcement:Z-0493-2014

Official wording

Reason: 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.

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

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label, and patient label all have the incorrect