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Stryker Instruments Div. of Stryker Corporation recalls RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Uni
Recalled July 24, 2013 · FDA recall Z-1742-2013 · Stryker Instruments Div. of Stryker
Hazard
The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100 · FDA Class II
Units
9
Sold at
Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
Description
The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100
Product
RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →