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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 001 11 12 000
Date submitted: 11/5/2012
Manufacturer:Stryker Osteosynthesis
Device Type:Orthopedic external fixation system, fracture, Wire Bolts Hoffmann LRF
Description:Orthopedic external fixation system, fracture
Medical Device Identifier:Manufacturer Part Number (Lot Numbers): 1- 4933-1-001 (Z02804, Z08348, Z08350, Z12549, Z16753 ); 2- 4933-1-002 (Z08351, Z12554, Z16246, Z16752 ); 3- 4933-1-003 (Z08349, Z09344, Z12551, Z16996 )
Reason of Field Safety Corrective Action:Two complaints have been filed where Hoffmann LRF Wires have broken during load bearing application by patients. The reported Hoffmann LRF Wire failures may have been caused by fatigue fracture in combination with the Hoffmann LRF Wire Bolts.
Remedy Action:1- Hoffmann LRF Wire Bolts should not be used for upcoming procedures. 2- All patients having a Hoffmann LRF frame with Wire Bolts should be immediately advised by their surgeon to avoid weight-bearing situations. 3- If Hoffmann LRF frame experienced a loss of fixation an alternative external fixation system should be considered. 4- Identify affected product in your inventory, return it to Stryker.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCAR
Source Ref. Number:CH-2012-10-26-064
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: CH-2012-10-26-064_Stryker_Hoffmann_LFR_Wire_Bolts_PFA_2012-154_FSN.pdf