Device product
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Z-0493-2014
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
label, and patient label all have the incorrect