CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
Reported: March 4, 2020 Initiated: January 10, 2020 #Z-1380-2020
Product Description
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
Reason for Recall
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
Details
- Recalling Firm
- Biomet 3i, LLC
- Units Affected
- N/A
- Distribution
- Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466. Recalled by Biomet 3i, LLC. Units affected: N/A.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2020. Severity: Moderate. Recall number: Z-1380-2020.
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