3I Osseotite Certain Dental Implants

• • Terminated Z-2845-2016 FDA Class II ·initiated 8 Aug 2016

  Product was incorrectly packaged.

• 5 recalls, same reason

  • Terminated Z-2483-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2520-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2485-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2516-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2488-2016 FDA Class II ·initiated 25 Nov 2015

  Pouches may not have been sealed during packing.

• • Terminated Z-2208-2013 FDA Class II ·initiated 10 Jun 2013

  One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.

• • Terminated Z-0119-2013 FDA Class II ·initiated 3 Aug 2012

  Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.

• • Terminated Z-2158-2012 FDA Class II ·initiated 23 Mar 2012 ·on shared 510(k) K063341

  Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.

• • Terminated Z-1828-2012 FDA Class II ·initiated 4 Nov 2011

  On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K063341 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• 3I Dental Implant Accessories

  Class II

  FDA 510(k) K022113 Active Cleared 19 Sep 2002

• Modification to Osseotite Nt Certain Implants

  Class II

  FDA 510(k) K041402 Active Cleared 16 Jun 2004

• 3I Calcium Sulfate Bone Cement

  Class II

  FDA 510(k) K012047 Active Cleared 19 Sep 2001

• Provide Temporary Cylinder

  Class II

  FDA 510(k) K061177 Active Cleared 16 May 2006

• 3I Implants; Osseotite Dental Implants; Osseotite Nt Dental Implants

  Class II

  FDA 510(k) K022009 Active Cleared 30 Dec 2002

• TIL313 Abutment and Retaining Screw Systems

  Class II

  FDA 510(k) K962465 Active Cleared 20 Sep 1996

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