FDA Device recall Z-0077-2021
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4 by Biomet 3i, citing 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, t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0077-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-31 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet 3i |
| Distribution | FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA |
Product
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Reason
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
Identifiers
| code_info | Lot Numbers: 8560281-1 8560299-1 8561332-3 8561476-1 8563315-1 8564057-1 8564060-3 8564060-4 8564064-1 856452…Lot Numbers: 8560281-1 8560299-1 8561332-3 8561476-1 8563315-1 8564057-1 8564060-3 8564060-4 8564064-1 8564524-1 8564524-2 8565357-1 8565414-3 8566637-1 8566637-2 8566648-1 8566969-2 8567559-1 8567578-1 8568041-1 8568705-1 8568819-1 8569841-7 8569987-1 8570625-1 8570737-1 8571824-1 8571843-1 8571850-1 8571866-1 8571887-4 8571887-5 8572228-1 8572238-1 8572238-2 UDI: (01)00844868031185(10)8560281-1 (01)00844868031185(10)8560299-1 (01)00844868031185(10)8561332-3 (01)00844868031185(10)8561476-1 (01)00844868031185(10)8563315-1 (01)00844868031185(10)8564057-1 (01)00844868031185(10)8564060-3 (01)00844868031185(10)8564060-4 (01)00844868031185(10)8564064-1 (01)00844868031185(10)8564524-1 (01)00844868031185(10)8564524-2 (01)00844868031185(10)8565357-1 (01)00844868031185(10)8565414-3 (01)00844868031185(10)8566637-1 (01)00844868031185(10)8566637-2 (01)00844868031185(10)8566648-1 (01)00844868031185(10)8566969-2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0077-2021%22
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