G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Reported: January 1, 2014 Initiated: November 26, 2013 #Z-0493-2014
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000. Recalled by Biomet, Inc.. Units affected: 532 in USA all under Biomet USA control.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2014. Severity: Moderate. Recall number: Z-0493-2014.
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