CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report
Certain Bellatek Encode Healing Abutment(D) X(P)(H) recalled
Biomet 3i is recalling Certain Bellatek Encode Healing Abutment(D) X(P)(H) Reference Number: IEHA346, distributed nationwide in the US. The recall was initiated on 10 Jan 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-1368-2020
- FDA event ID
- 84771
- Recalling firm
- Biomet 3i, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2020
- FDA classified
- 26 Feb 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Jan 2020 | Recall initiated by company | |
| 26 Feb 2020 | Classified by FDA | +47 days |
| 4 Mar 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
Where it was distributed
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
Questions about this recall
Why was it 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
Which lots are affected?
Lot Numbers: 1228247
Where was it sold?
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
22 other products · FDA event 84771This product is part of a recall event; the main page for the event is Certain Bellatek Encode Healing Abutment(D)(P)(H) Reference recalled.
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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