Certain Bellatek Titanium Abutment 6.0mm recall
CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
Why was Certain Bellatek Titanium Abutment 6.0mm recalled?
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
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 Number: 8562282-1 UDI: (01)00844868031208(10)8562282-1
- Product
- CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 1 unit
- Distribution
- FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
- Recall date
- October 14, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)