Recall Z-1587-2015— Stryker Instruments Div. of Stryker Corporation

Class III FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2015-03-25, terminated 2015-07-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments.. Reason: The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue..

Recalling firm

Stryker Instruments Div. of Stryker Corporation

Classification

Class III

Status

Terminated

Initiated

2015-03-25

Terminated

2015-07-08

Firm location

Portage, MI, United States

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