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Synthes USA HQ, Inc.

150 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
02.122.600, 100mm Spiral Blade, 14mm, Right- Synthes Spiral Blade Component of the Synthes recall (Z-1299-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.601, 100mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1301-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.601S, 100mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of th recall (Z-1302-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.605, 105mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthe recall (Z-1303-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.605S, 105mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of t recall (Z-1304-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.606, 105mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1305-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.606S, 105mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of th recall (Z-1306-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.610, 110mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthe recall (Z-1307-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.610s, 110mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of t recall (Z-1308-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.611, 110mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1309-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.611S, 110mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of th recall (Z-1310-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthe recall (Z-1311-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.615S, 115mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of t recall (Z-1312-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.616, 115mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1313-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.616S, 115mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of th recall (Z-1314-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthe recall (Z-1315-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.620S, 120mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of t recall (Z-1316-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.621, 120mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1317-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.621S, 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of th recall (Z-1318-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of t recall (Z-300-2011)Synthes USA (HQ), Inc.2011-02-16
3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislo recall (Z-0309-2011)Synthes USA (HQ), Inc.2010-11-02
TI N-Hance Rod 150mm Sterile The Synthes N-Hance and NFix II rods are intended to provide recall (Z-2344-2010)Synthes USA (HQ), Inc.2010-09-01
N-Hance System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobili recall (Z-2345-2010)Synthes USA (HQ), Inc.2010-09-01
NFix II System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobili recall (Z-2346-2010)Synthes USA (HQ), Inc.2010-09-01
NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are intended to recall (Z-2347-2010)Synthes USA (HQ), Inc.2010-09-01
NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to prov recall (Z-2348-2010)Synthes USA (HQ), Inc.2010-09-01
Synthes Medullary Tubes recall (Z-1804-2010)Synthes USA (HQ), Inc.2010-06-16
7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium Solid recall (Z-1548-2010)Synthes USA (HQ), Inc.2010-05-07
7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid recall (Z-1549-2010)Synthes USA (HQ), Inc.2010-05-07
Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S. recall (Z-0825-2010)Synthes USA (HQ), Inc.2010-02-24
Norian CRS Rotary Mixer Cement 10cc sterile recall (Z-0269-2010)Synthes USA (HQ), Inc.2009-11-16
Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001. Intende recall (Z-0108-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002. Intende recall (Z-0109-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number 04.808.003. Intende recall (Z-0110-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intende recall (Z-0111-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number 04.808.005. Intende recall (Z-0112-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006. Intende recall (Z-0113-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007. Intende recall (Z-0114-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. Intende recall (Z-0115-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number 04.808.009. Intende recall (Z-0116-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010. Intend recall (Z-0117-2010)Synthes USA (HQ), Inc.2009-11-09
Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number 04.808.011. Intend recall (Z-0118-2010)Synthes USA (HQ), Inc.2009-11-09
SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mand recall (Z-0075-2010)Synthes USA (HQ), Inc.2009-10-26
SYNTHES BENDING PLIERS - STRAIGHT FOR CRANIOFACIAL/ORTHOGNATHIC PL, Catalog # SD347.967. S recall (Z-0076-2010)Synthes USA (HQ), Inc.2009-10-26
SYNTHES PLATE HOLDING FORCEPS, Catalog # SD347.900 recall (Z-0077-2010)Synthes USA (HQ), Inc.2009-10-26
SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/39MM, Catalog # SD448.003. Synthe recall (Z-0078-2010)Synthes USA (HQ), Inc.2009-10-26
SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM, Catalog # SD448.004. Synthe recall (Z-0079-2010)Synthes USA (HQ), Inc.2009-10-26
SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/45MM, Catalog # SD448.005. Synthe recall (Z-0080-2010)Synthes USA (HQ), Inc.2009-10-26
SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/48MM, Catalog # SD448.006. Synthe recall (Z-0081-2010)Synthes USA (HQ), Inc.2009-10-26
SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853. Synthes Titanium Matrix M recall (Z-0082-2010)Synthes USA (HQ), Inc.2009-10-26
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