Z-2594-2014 Class II Terminated
FDA device recall Z-2594-2014 was initiated by Biomet 3I, LLC on Jun 25, 2014 and is designated Class II. Reason for recall: Identifiers on the label are correct but the label has the incorrect color coding. The recall status is terminated (terminated Sep 23, 2014). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 17, 2014
- Initiation Date
- Jun 25, 2014
- Termination Date
- Sep 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
Reason for Recall
Identifiers on the label are correct but the label has the incorrect color coding.
Distribution Pattern
US Distribution to NH and TX.
Code Information
Model Number IEHA458, Lot number: 1167545.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2594-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026