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Synthes USA HQ, Inc.

150 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen recall (Z-0615-2014)Synthes USA HQ, Inc.2013-12-31
Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and c recall (Z-0473-2014)Synthes USA HQ, Inc.2013-12-10
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) recall (Z-0474-2014)Synthes USA HQ, Inc.2013-12-10
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable frac recall (Z-0452-2014)Synthes USA HQ, Inc.2013-12-05
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM recall (Z-0455-2014)Synthes USA HQ, Inc.2013-12-05
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation recall (Z-0429-2014)Synthes USA HQ, Inc.2013-11-29
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is recall (Z-0405-2014)Synthes USA HQ, Inc.2013-11-27
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilizatio recall (Z-0407-2014)Synthes USA HQ, Inc.2013-11-27
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of recall (Z-0408-2014)Synthes USA HQ, Inc.2013-11-27
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal recall (Z-0409-2014)Synthes USA HQ, Inc.2013-11-27
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into v recall (Z-0410-2014)Synthes USA HQ, Inc.2013-11-27
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking recall (Z-0390-2014)Synthes USA HQ, Inc.2013-11-26
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left recall (Z-0391-2014)Synthes USA HQ, Inc.2013-11-26
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL recall (Z-0393-2014)Synthes USA HQ, Inc.2013-11-26
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligamen recall (Z-0394-2014)Synthes USA HQ, Inc.2013-11-26
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Numb recall (Z-0395-2014)Synthes USA HQ, Inc.2013-11-26
Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631 recall (Z-0396-2014)Synthes USA HQ, Inc.2013-11-26
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD recall (Z-0401-2014)Synthes USA HQ, Inc.2013-11-26
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compr recall (Z-0387-2014)Synthes USA HQ, Inc.2013-11-25
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for recall (Z-0388-2014)Synthes USA HQ, Inc.2013-11-25
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures recall (Z-0380-2014)Synthes USA HQ, Inc.2013-11-22
Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw recall (Z-0384-2014)Synthes USA HQ, Inc.2013-11-22
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochante recall (Z-0369-2014)Synthes USA HQ, Inc.2013-11-20
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation o recall (Z-0341-2014)Synthes USA HQ, Inc.2013-11-18
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is recall (Z-0202-2014)Synthes USA HQ, Inc.2013-11-13
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or seco recall (Z-0114-2014)Synthes USA HQ, Inc.2013-10-30
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, n recall (Z-0014-2014)Synthes USA HQ, Inc.2013-10-17
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The O recall (Z-2282-2013)Synthes USA HQ, Inc.2013-09-26
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System i recall (Z-2278-2013)Synthes USA HQ, Inc.2013-09-25
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. recall (Z-2243-2013)Synthes USA HQ, Inc.2013-09-18
Synthes Trauma Nail System. The devices are indication for bone fixation. recall (Z-2058-2013)Synthes USA HQ, Inc.2013-08-26
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended recall (Z-2087-2013)Synthes USA HQ, Inc.2013-08-26
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of th recall (Z-1952-2013)Synthes USA HQ, Inc.2013-08-12
5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm recall (Z-1935-2013)Synthes USA HQ, Inc.2013-08-09
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, recall (Z-1816-2013)Synthes USA HQ, Inc.2013-07-29
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Ho recall (Z-1821-2013)Synthes USA HQ, Inc.2013-07-29
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of recall (Z-1745-2013)Synthes USA HQ, Inc.2013-07-17
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and le recall (Z-1726-2013)Synthes USA HQ, Inc.2013-07-12
Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011 recall (Z-1557-2013)Synthes USA HQ, Inc.2013-06-19
Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial H recall (Z-1238-2013)Synthes USA HQ, Inc.2013-05-03
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conven recall (Z-1062-2013)Synthes USA HQ, Inc.2013-04-05
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the An recall (Z-1016-2013)Synthes USA HQ, Inc.2013-03-28
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02 recall (Z-0956-2013)Synthes USA HQ, Inc.2013-03-15
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary st recall (Z-0942-2013)Synthes USA HQ, Inc.2013-03-12
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part N recall (Z-0938-2013)Synthes USA HQ, Inc.2013-03-11
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: recall (Z-0941-2013)Synthes USA HQ, Inc.2013-03-11
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening recall (Z-0903-2013)Synthes USA HQ, Inc.2013-03-01
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487. recall (Z-0904-2013)Synthes USA HQ, Inc.2013-03-01
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487. recall (Z-0905-2013)Synthes USA HQ, Inc.2013-03-01
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusi recall (Z-0781-2013)Synthes USA HQ, Inc.2013-02-04
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusi recall (Z-0782-2013)Synthes USA HQ, Inc.2013-02-04
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use recall (Z-0277-2013)Synthes USA HQ, Inc.2012-11-13
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous i recall (Z-0001-2013)Synthes USA HQ, Inc.2012-10-01
Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001. recall (Z-2206-2012)Synthes USA HQ, Inc.2012-08-16
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufac recall (Z-2059-2012)Synthes USA HQ, Inc.2012-07-23
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufac recall (Z-2060-2012)Synthes USA HQ, Inc.2012-07-23
Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual recall (Z-0676-2012)Synthes USA (HQ), Inc.2012-01-11
Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical inst recall (Z-0348-2012)Synthes USA (HQ), Inc.2011-12-02
Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer syste recall (Z-0161-2012)Synthes USA (HQ), Inc.2011-11-04
Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fu recall (Z-0104-2012)Synthes USA (HQ), Inc.2011-10-21
Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) recall (Z-3273-2011)Synthes USA (HQ), Inc.2011-09-21
Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intend recall (Z-3207-2011)Synthes USA (HQ), Inc.2011-09-15
02.122.550, 50mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1261-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.550S, 50mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1262-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.551, 50mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1263-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.551S, 50mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1264-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1265-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1266-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.556, 55mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1267-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.556S, 55mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1268-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.561, 60mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1269-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1270-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1271-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.565S, 65mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1272-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.566, 65mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1273-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.566S, 65mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1274-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.570, 70mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1275-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.570S, 70mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1276-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.571, 70mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1277-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.571S, 70mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1278-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.575, 75mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1279-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.575S, 75mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1280-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.576, 75mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1281-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.576S, 75mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1282-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.580, 80mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1283-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.580S, 80mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1284-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.581, 80mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1285-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.581S, 80mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1286-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.585, 85mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1287-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.585S, 85mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1288-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.586, 85mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1289-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.586S, 85mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1290-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.590, 90mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1291-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1292-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.591, 90mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1293-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1294-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.595, 95mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1295-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1296-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.596, 95mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1297-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.596S, 95mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1298-2011)Synthes USA (HQ), Inc.2011-02-16
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