CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report

Certain Bellatek Encode Healing Abutment(D)(P)(H) Reference recalled

Biomet 3i is recalling Certain Bellatek Encode Healing Abutment(D)(P)(H) Reference Number: IEHA443, 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

Lot, batch or date codesLot Numbers: 1227135, 1228599

Quantity recalledN/A

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-1372-2020
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 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443

Where it was distributed

Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK

Nationwide

Questions about this recall

Is Certain Bellatek Encode Healing Abutment(D)(P)(H) Reference Number: IEHA443 recalled?

Yes. Biomet 3i recalled Certain Bellatek Encode Healing Abutment(D)(P)(H) Reference Number: IEHA443 on 10 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1372-2020.

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: 1227135, 1228599

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 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.

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