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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 056 07 17 000
Date submitted: 7/12/2017
Manufacturer:Stryker Instruments
Device Type:Stryker System G handpieces
Description:surgical battery-powered instruments intended for use during a variety of orthopedic and trauma procedures
Medical Device Identifier:7308-001-000 Sagittal Saw, 7306-001-000 Reciprocating Saw, 7305-001-000 Rotary Drill Devices
Reason of Field Safety Corrective Action:Information has been updated in the Care Instructions to reflect that the recommended Ethylene Oxide (EO) Sterilization time should be 80 minutes, up from 60 minutes previously.
Remedy Action:1. Immediately review this Recall Notification.

2. Enclosed is a revised version of the System G handpiece Care Instructions. Please distribute the revised version to the appropriate person or department.

3. Remove and discard any previously distributed System G handpiece Care Instructions.

4. Please complete and sign the enclosed Business Reply Form (BRF), acknowledging your receipt and understanding of this Notification.

5. Return the completed BRF to Manufacturer.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System
Report Source:NCMDR
Source Ref. Number:DE4C369A5D257
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Stryker.pdf