Recall Z-0584-2017— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-0584-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-11

Class III · Terminated

Class III FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2016-10-11, terminated 2017-07-25. It names one FDA 510(k) clearance: K071482. Product: RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U. Reason: Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class III
Status: Terminated
Initiated: 2016-10-11
Terminated: 2017-07-25
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K071482 — STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000Synergetics, Inc.·cleared 2007-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

Reason for recall

Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.

Data sourced from openFDA. This site is unofficial and independent of the FDA.