CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report
O-Ring Abutment(D)(H) recalled by Biomet 3i
Biomet 3i is recalling O-Ring Abutment(D)(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
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-2425-2016
- 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
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 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.
Questions about this recall
Why was it recalled?
Pouches may not have been sealed during packing.
Which lots are affected?
Lot # 1014104, 1022991, 1033058, 1041417, 1052716, 1054542, 1060675, 1069646, 1088483, 1094776, 1106610, 1129686, 1141289, 1168523, 1168829, 1172024, and 996069.
Where was it sold?
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.
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
100 other products · FDA event 73184This product is part of a recall event; the main page for the event is Certain Straight Healing Abutment(D) x(P)(H) recalled by Biomet 3i.
More recalls from Biomet 3i
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|---|---|---|---|---|---|
| Device | CLASS II | Certain Bellatek Tin Abutment Reference Number: IEDAN5 recalled | Biomet 3i | Other | 11 states |
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| 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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| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |