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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 042 01 16 000
Date submitted: 1/12/2016
Manufacturer:DePuySynthes
Device Type:Extraction Screw for PFNA Blade
Description:The Extraction Screw for PFNA Blade is a part of the PFNA and PFNA II Systems.
Medical Device Identifier:Part Number : 356.825

Lot Numbers : 2089467; 2090743; 2101443; 2103560; 2107022; 2107094; 2109115; 2114311; 2119302; 2125711; 2127225; 2135962; 2145558; 2155648; 2162089; 2163636; 2168449; 2186602; 2187918; 2193852; 2203709; 2216008; 2225226; 2225992; 2234804; 2238532; 2238533; 2257480; 2257481; 2263698; 2265892; 2311442; 2324437; 2354073; 2357959; 2370086; 2389952; 2401175; 2416428; 2442559; 2443570; 2450764; 2458359; 2475991; 2484015; 2485474; 2498270
Reason of Field Safety Corrective Action:Through a complaint investigation, it was discovered that the affected lots of the Extraction Screw could break or disassemble from the instrument. This may interfere with removal of the PFNA and PFNA-II Blade from the patient.
Remedy Action:- Immediately identify and quarantine all unused products listed above in a manner that ensures the affected products will not be used.

- Return any affected product as soon as possible
Athorized Representative/Importer/Distributor:Isam Economic Co.
Report Source:NCMDR
Source Ref. Number:F7D542F089387
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: DePuySynthes.pdf