Stryker Instruments Div. of Stryker product recalled over sterility concerns

Recall date

March 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Instruments Div. of Stryker Corporation recalls Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and p…

Recall number

Z-1587-2015

FDA classification

Class III

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

US Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, MS, MT, NC, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and the foreign country of: Canada

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.