Recall Z-1587-2015 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Stryker Instruments Div. of Stryker Corporation
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
| Date | May 7, 2015 (initiated Mar 25, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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. |
| Quantity | 223 chargers |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.