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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 094 10 11 000
Date submitted: 10/31/2011
Manufacturer:Stryker
Device Type:Inferior Border Osteotomy (IBO) blades
Description:IBO, blades
Medical Device Identifier:Catalogue No: 5100-037-901; 5100-037-902; 5100-037-903; 5100-037-901S2; 5100-037-902S2 Lot No: All lots manufactured from the 31st July 31 2006 to 15th June 2011 All lots with expiry dates from 1st July 2011 to 1st July 2016
Reason of Field Safety Corrective Action:There is potential for the blade to break from the arbor while the surgeon is cutting mandibular bone. The broken piece may: 1. Fall into the surgical site. This may result in possible: a. Delay in surgery time whilst the surgeon removes the part and obtains a replacement device The probability of occurrence is low. 2. Be swallowed or aspirated into the lungs. This may result in possible: a. Delay in surgery time b. Tissue damage c. Need for further surgery to remove the part. d. Infection should the part not be removed The probability of occurrence is negligible. 3. Become lodged in the mandibular bone. This may result in possible: a. Delay in surgery time b. Need for further surgery to remove the part c. Need for x-rays and MRI scans to locate the part i. MRI rays may cause temporary temperature changes of the remaining implanted part. d. Infection should the part not be removed The probability of occurrence is remote.
Remedy Action:Immediately locate and quarantine all subject devices. Stryker representative will contact you to arrange for replacement of any non conforming devices.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD, Riyadh, (01) 4041717
Report Source:NCMDR
Source Ref. Number:764F9E43CF275
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments