Z-0493-2014 Class II Terminated
FDA device recall Z-0493-2014 was initiated by Biomet, Inc. on Nov 26, 2013 and is designated Class II. 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… The recall status is terminated (terminated Sep 29, 2014). Affected quantity: 532 in USA all under Biomet USA control.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 1, 2014
- Initiation Date
- Nov 26, 2013
- Termination Date
- Sep 29, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 532 in USA all under Biomet USA control
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.
Distribution Pattern
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0493-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026