Recall Z-1598-2018— Stryker Medical Division of Stryker Corporation

Class II · Terminated

Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2018-03-09, terminated 2019-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 6376 M-1 Cot Fastener, catalog no. 6376000000. Reason: The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information..

Recalling firm
Stryker Medical Division of Stryker Corporation
Classification
Class II
Status
Terminated
Initiated
2018-03-09
Terminated
2019-04-09
Firm location
Portage, MI, United States

Product description

6376 M-1 Cot Fastener, catalog no. 6376000000

Reason for recall

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

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