CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report
Certain Bellatek Titanium Abutment Reference Number: IEDAT5 recalled
Biomet 3i is recalling Certain Bellatek Titanium Abutment Reference Number: IEDAT5, distributed in 11 states. The recall was initiated on 31 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0078-2021
- FDA event ID
- 86402
- Recalling firm
- Biomet 3i, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2020
- FDA classified
- 8 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Aug 2020 | Recall initiated by company | |
| 8 Oct 2020 | Classified by FDA | +38 days |
| 14 Oct 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
Where it was distributed
FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
FloridaGeorgiaIdahoIllinoisMichiganNevadaNew YorkOhioSouth CarolinaTennesseeVirginia
Questions about this recall
Is Certain Bellatek Titanium Abutment Reference Number: IEDAT5 recalled?
Yes. Biomet 3i recalled Certain Bellatek Titanium Abutment Reference Number: IEDAT5 on 31 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-0078-2021.
Why was it 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
Which lots are affected?
Lot Numbers: 8561074-1 8563880-1 8564060-1 8565449-1 8565945-1 8566616-1 8568052-1 8568808-1 8569206-1 8571880-1 UDI: (01)00844868031192(10)8561074-1 (01)00844868031192(10)8563880-1 (01)00844868031192(10)8564060-1 (01)00844868031192(10)8565449-1 (01)00844868031192(10)8565945-1 (01)00844868031192(10)8566616-1 (01)00844868031192(10)8568052-1 (01)00844868031192(10)8568808-1 (01)00844868031192(10)8569206-1 (01)00844868031192(10)8571880-1
Where was it sold?
FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biomet 3i
All 222| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Certain Bellatek Tin Abutment Reference Number: IEDAN5 recalled | Biomet 3i | Other | 11 states |
| Device | CLASS II | Certain Bellatek Titanium Abutment Reference Number: IEDAT6 recalled | Biomet 3i | Other | 11 states |
| Device | CLASS II | BellaTek Encode Defin3DPMSERitive Abutments-3D Printed recalled | Biomet 3i | Other | 11 states |
| Device | CLASS II | Certain Bellatek Titanium Abutment Reference Number: IEDAT4 recalled | Biomet 3i | Other | 11 states |
| Device | CLASS II | Certain Bellatek Tin Abutment Reference Number: IEDAN4 recalled | Biomet 3i | Other | 11 states |
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