Bone-Temno/Sternum-Temno

• • Terminated Z-0154-2022 FDA Class II ·initiated 24 Aug 2021 ·on shared 510(k) K913306

  Due to misbranded products shipped to customers.

• 3 recalls, same reason

  • Terminated Z-1423-2018 FDA Class II ·initiated 23 Feb 2017 ·on shared 510(k) K913306
  • Terminated Z-1425-2018 FDA Class II ·initiated 23 Feb 2017 ·on shared 510(k) K913306
  • Terminated Z-1424-2018 FDA Class II ·initiated 23 Feb 2017 ·on shared 510(k) K913306

  The integrity of the sterile packaging is potentially compromised.

• • Terminated Z-0590-2011 FDA Unclassified (pre-2012) ·initiated 18 Oct 2010

  Outer cartons for the product may be labeled with incorrect needle gauge.

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

510(k) Number

K913306 ↗

FDA Product Code

LWE

Device Class

Class II

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Proact 1

  Class II

  FDA 510(k) K003909 Active Cleared 13 Jun 2001

• Quick Core II

  Class II

  FDA 510(k) K941256 Active Cleared 13 Jul 1994

• Proact Biopsy Needle Enchancements

  Class II

  FDA 510(k) K926559 Active Cleared 22 Mar 1993

• Bauer Temno Biopsy Needle

  Class II

  FDA 510(k) K902319 Active Cleared 6 Sep 1990

• Flexi-Temno Biopsy Needle

  Class II

  FDA 510(k) K902320 Active Cleared 1 Oct 1990

• Proact with Gel or Proact 1

  Class II

  FDA 510(k) K052243 Active Cleared 12 Apr 2006