Reprocessed Arthroscopic Shapers

• 2 recalls, same reason

  • Terminated Z-1641-2013 FDA Class II ·initiated 3 May 2013 ·on shared 510(k) K012667
  • Terminated Z-1633-2013 FDA Class II ·initiated 3 May 2013

  The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

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

510(k) Number

K012667 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) Open recall

  Class II

  FDA 510(k) K250545 Active Cleared 5 Jun 2025

• Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

  Unclassified

  FDA 510(k) K173627 Active Cleared 12 Jul 2018

• Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

  Class II

  FDA 510(k) K171324 Active Cleared 23 Jun 2017

• ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) Open recall

  Class II

  FDA 510(k) K232511 Active Cleared 29 Apr 2024

• Medisiss Reprocessed Ultrasonic Instruments

  Unclassified

  FDA 510(k) K124033 Active Cleared 7 Jan 2014

• Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and Accessories

  Class II

  FDA 510(k) K031869 Active Cleared 24 Dec 2003

See all devices from Surgical Instruments Service and Savings, Inc. →