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Biomet, Inc. recalls G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Recalled January 1, 2014 · FDA recall Z-0493-2014 · Biomet
Hazard
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. · FDA Class II
Units
532 in USA all under Biomet USA control
Sold at
Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.
Description
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.
Product
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →