CLASS II Device recall · Reported 22 Apr 2015 · FDA Enforcement Report
3i T3 Non-Platform Switched Tapered Implant recalled by Biomet 3i
Biomet 3i is recalling 3i T3 Non-Platform Switched Tapered Implant, distributed nationwide in the US. The recall was initiated on 7 Nov 2014 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-1409-2015
- FDA event ID
- 70628
- Recalling firm
- Biomet 3i, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Nov 2014
- FDA classified
- 10 Apr 2015
- Reported
- 22 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 7 Nov 2014 | Recall initiated by company | |
| 10 Apr 2015 | Classified by FDA | +154 days |
| 22 Apr 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Product as listed by the FDA
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Where it was distributed
Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIllinoisKentuckyLouisianaMassachusettsMarylandMichiganNorth CarolinaNew HampshireNew JerseyNew YorkOhio
Questions about this recall
Is 3i T3 Non-Platform Switched Tapered Implant recalled?
Yes. Biomet 3i recalled 3i T3 Non-Platform Switched Tapered Implant on 7 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-1409-2015.
Why was it recalled?
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Which lots are affected?
Implant PN # BOST3211 Lot # 2014051395 Exp date 12/11/2018 and Lot # 2014051817 Exp date 12/09/2018
Where was it sold?
Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
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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