Certain Bellatek Encode Healing Abutment 5mm(d) X recall
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
Why was Certain Bellatek Encode Healing Abutment 5mm(d) X 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 1228904 1230638
- Product
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
- Recalling firm
- Biomet 3i, LLC
- Quantity
- N/A
- Distribution
- Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
- Recall date
- March 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)