X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 052 03 15 001
Date submitted: 9/15/2015
Manufacturer:DePuysynthes
Device Type: Pedicle Awl 4.0mm w/Canevasit Handle : Pedicle Awl 4.0mm w/Silicone Handle
Description:Screw fixation system
Medical Device Identifier:
- Technique Guide Description : ( Technique Guide Number)
Pangea Spine System, Technique Guide : (036.000.080)
USS II Polyaxial Spine System, Technique Guide : (036.000.216)
MATRIX Spine System - Deformity, Technique Guide : (036.001.180)
MATRIX Spine System - Degenerative, Technique Guide: (036.001.185)

- Affected Labeling Description : (Product Code)
Pedicle Awl4.0mm w/Canevasit Handle : (388.550)
Pedicle Awl4.0mm w/Silicone Handle : 388.656

........................................

NCMDR update Codes :
Technique Guide Description : *Pangea Degenerative, Technique Guide
Technique Guide Number : 036.000.445
Reason of Field Safety Corrective Action:Technique Guides for these four systems describe the Pedicle Awls as 4.0mm for use with screws (4.0mm to 7.0mm). These awls should be used with 5.0mm to 7.0mm screws.
Remedy Action:1) Review the revisions being made to surgical Technique Guides and outer labels.
2) Forward this notice to anyone in your facility that needs to be informed.
3) If any of the affected Technique Guides or outer labels have been forwarded to another facility, contact that facility to inform them of revisions.
4) Maintain awareness of this notice until all Technique Guides and outer labels have been updated.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (011) 4142200
Report Source:NCMDR
Source Ref. Number:DE94664553270
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: DePuySynthes.pdf