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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 10 Results
510(K) Number: K063341
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Product Description
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Class
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FDA Recall
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3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only. 2 09/19/2016 Biomet 3i, LLC
Certain Implant Cover Screw Dental implants 2 08/12/2016 Biomet 3i, LLC
Certain Flat Implant Cover Screw Dental implants 2 08/12/2016 Biomet 3i, LLC
Certain Cover Screw Dental implants 2 08/12/2016 Biomet 3i, LLC
Certain Micromini Flat Implant Cover Screw Dental implants 2 08/12/2016 Biomet 3i, LLC
Certain Implant Straight Cover Screw Dental implants 2 08/12/2016 Biomet 3i, LLC
Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placem... 2 09/16/2013 Biomet 3i, LLC
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended fo... 2 10/23/2012 Biomet 3i, LLC
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only*... 2 08/08/2012 Biomet 3i, LLC
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is la... 2 06/20/2012 Biomet 3i, LLC
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