Z-0079-2021 Class II Terminated
FDA device recall Z-0079-2021 was initiated by Biomet 3i, LLC on August 31, 2020 and is designated Class II. Reason for recall: 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 abutmen… The recall status is terminated (terminated July 6, 2022). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- August 31, 2020
- Termination Date
- July 6, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
Reason for Recall
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
Distribution Pattern
FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
Code Information
Lot Number: 8562282-1 UDI: (01)00844868031208(10)8562282-1