FDAJanuary 10, 2020device
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
biomet 3ibiomet
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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