Conical Angled Abutment

• 4 recalls, same reason

  • Terminated Z-2514-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2513-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2505-2016 FDA Class II ·initiated 25 Nov 2015
  • Terminated Z-2504-2016 FDA Class II ·initiated 25 Nov 2015

  Pouches may not have been sealed during packing.

• • Terminated Z-0158-2012 FDA Unclassified (pre-2012) ·initiated 28 Sep 2011

  On 09/28/2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Conical Angled Abutment, Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for the referenced products may not have been completely sealed prior to shipment.

510(k) Number

K063403 ↗

FDA Product Code

NHA

Device Class

Class II

Regulation

21 CFR Part 872.3630

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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