CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report

Certain EP Healing Abutment(D)(P)(H) recalled by Biomet 3i

Biomet 3i is recalling Certain EP Healing Abutment(D)(P)(H), distributed nationwide in the US. The recall was initiated on 25 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 1153081

Quantity recalled1,648,273 (all products subject to these recall)

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-2407-2016
FDA event ID: 73184
Recalling firm: Biomet 3i, Palm Beach Gardens, FL
Classification: Class II
Status: Terminated
Recall initiated: 25 Nov 2015
FDA classified: 16 Aug 2016
Reported: 24 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Dental Devices

Timeline

25 Nov 2015	Recall initiated by company
16 Aug 2016	Classified by FDA	+265 days
24 Aug 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Pouches may not have been sealed during packing.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants

Where it was distributed

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Nationwide Puerto Rico

Questions about this recall

Is Certain EP Healing Abutment(D)(P)(H) recalled?

Yes. Biomet 3i recalled Certain EP Healing Abutment(D)(P)(H) on 25 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-2407-2016.

Why was it recalled?

Pouches may not have been sealed during packing.

Which lots are affected?

Lot # 1153081

Where was it sold?

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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