Inside Job

• • Terminated Z-2222-2019 FDA Class II ·initiated 26 Jun 2019

  There was a higher than normal incidence rate of the blade not retracting when tightening.

• • Terminated Z-2107-2018 FDA Class II ·initiated 19 Apr 2018

  The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.

510(k) Number

K912871 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Model 480cm Infusion Pump, Modification

  Class II

  FDA 510(k) K924869 Active Cleared 17 Jun 1993

• 3M Prevention Fabric Surgical Gown #78XX

  Class II

  FDA 510(k) K930681 Active Cleared 10 Feb 1994

• 3M Precise Brand Internal Surgical Staples

  Class II

  FDA 510(k) K921051 Active Cleared 16 Jul 1992

• 3M Pediatric Laparotomy Sheet #7938/ #7938NS

  Class II

  FDA 510(k) K946024 Active Cleared 8 Feb 1995

• 3M X-Large Sheet #7979/ #7979NS

  Class II

  FDA 510(k) K946025 Active Cleared 2 Feb 1995

• Red Dot 2515 Cardiac Sensor System

  Class I

  FDA 510(k) K924487 Active Cleared 23 Dec 1992

See all devices from 3M Health Care, Ltd. →