FDAFDA · Food and drugs·Recall number Z-1376-2020
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
Published March 4, 2020 · Recall initiated: January 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet 3i, LLC
- Distributor
- Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
- Lot
- Lot Numbers: 1227498 1228248 1228639 1228692 1227504 1228863 1229535 1229557 1228807
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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