OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
Reported: April 22, 2015 Initiated: November 7, 2014 #Z-1410-2015
Product Description
OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
Reason for Recall
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Details
- Recalling Firm
- Biomet 3i, LLC
- Units Affected
- 620 implants in total
- Distribution
- 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.
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.. Recalled by Biomet 3i, LLC. Units affected: 620 implants in total.
Why was this product recalled? ▼
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2015. Severity: Moderate. Recall number: Z-1410-2015.
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