Newdeal Ankle Nail

• • Terminated Z-1539-2017 FDA Class II ·initiated 3 Mar 2017

  Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.

• • Terminated Z-1736-2013 FDA Class II ·initiated 9 May 2013

  As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.

• • Terminated Z-1428-2012 FDA Unclassified (pre-2012) ·initiated 19 May 2011

  The firm received multiple complaints from their user customers (surgeons) who reported encountering difficulty inserting a calcaneal or tibial screw through the holes of the PANTA nail.

• • Terminated Z-0308-2011 FDA Unclassified (pre-2012) ·initiated 1 Mar 2010

  Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (Panta Support Device).

• • Terminated Z-1877-2008 FDA Unclassified (pre-2012) ·initiated 24 Mar 2008

  Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails (Part Number 500050ND; Lot Number: E7XX) may present an insufficient depth and may not allow the engagement of the threaded part of the compression device. The risks presented include: an increase in surgery time, or the implantation of a nail less ideally suited for the patient's anatomy

510(k) Number

K050882 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Solustaple

  Class II

  FDA 510(k) K991566 Active Cleared 3 Aug 1999

• Modification to Ttc Plates

  Class II

  FDA 510(k) K070160 Active Cleared 8 Feb 2007

• Bold Screw

  Class II

  FDA 510(k) K990622 Active Cleared 29 Apr 1999

• The Uni-Clip Staple

  Class II

  FDA 510(k) K011716 Active Cleared 30 Aug 2001

• Kalix II Implant

  Class II

  FDA 510(k) K061765 Active Cleared 18 Jul 2006

• Spin Snap-Off Screw

  Class II

  FDA 510(k) K991477 Active Cleared 14 Jul 1999

See all devices from New Deal, S.A. →