CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report
3I Osseotite Certain Dental Implants, ., Sterile recalled by Biomet 3i
Biomet 3i is recalling 3I Osseotite Certain Dental Implants, ., Sterile, distributed in California, Florida. The recall was initiated on 8 Aug 2016 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-2845-2016
- FDA event ID
- 74896
- Recalling firm
- Biomet 3i, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2016
- FDA classified
- 19 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Dental Devices
Timeline
| 8 Aug 2016 | Recall initiated by company | |
| 19 Sep 2016 | Classified by FDA | +42 days |
| 28 Sep 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was incorrectly packaged.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Where it was distributed
US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
Questions about this recall
Is 3I Osseotite Certain Dental Implants, ., Sterile recalled?
Yes. Biomet 3i recalled 3I Osseotite Certain Dental Implants, ., Sterile on 8 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-2845-2016.
Why was it recalled?
Product was incorrectly packaged.
Which lots are affected?
Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.
Where was it sold?
US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
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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