Device product
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.
Z-2594-2014
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 68915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-2594-2014
Official wording
Reason: Identifiers on the label are correct but the label has the incorrect color coding.
Code information: Model Number IEHA458, Lot number: 1167545.
Distribution pattern: US Distribution to NH and TX.
Derived failure modes
-
Labeling or packaging
label are correct but the label has the incorrect