Recall Z-1255-2018— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1255-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-09

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2017-11-09, terminated 2019-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.. Reason: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-11-09
Terminated: 2019-04-16
Firm location: Portage, MI, United States

Product description

Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.

Reason for recall

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

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