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Terminated

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.

FDA Recall Z-1587-2015 · Posted 2015-05-07

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeHWE
Date Initiated2015-03-25
Date Terminated2015-07-08
Product Quantity223 chargers

Reason for Recall

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.

Firm Action

Stryker issued e-mail notices to distributors and reps on March 26, 2015 advising that all battery charges would receive a software update to provide a field correction for the upgrade to units to be able to track device usage data to Stryker as designed. There is no customer action required, the chargers will transmit a message to Stryker once the upgrade is complete. Please contact Kelly Jo Davis at 269-389-2921 with any questions.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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