Synthes, Inc.

FDA Regulatory Profile

Summary

Total Recalls
43 (1 Class I)
510(k) Clearances
26
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2698-2020Class IIMatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bonesJune 18, 2020
Z-0880-2020Class II2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile TDecember 16, 2019
Z-0883-2020Class II2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile TDecember 16, 2019
Z-0882-2020Class II2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile TDecember 16, 2019
Z-0881-2020Class II2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile TDecember 16, 2019
Z-0879-2020Class II2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile TDecember 16, 2019
Z-1514-2018Class IIStem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of March 19, 2018
Z-1511-2018Class IIFlex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive SuMarch 5, 2018
Z-0669-2018Class IILCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment SyAugust 7, 2017
Z-2051-2015Class IITITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes TibiJune 3, 2015
Z-2092-2015Class IIReamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer HeaMay 28, 2015
Z-1799-2015Class IIPull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick couplMay 28, 2015
Z-1915-2015Class IIDePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105May 27, 2015
Z-1711-2015Class II3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated DrilMay 13, 2015
Z-1800-2015Class II3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are inMay 13, 2015
Z-1600-2015Class IITFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and tApril 9, 2015
Z-1352-2015Class IISynthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree AiFebruary 24, 2015
Z-1281-2015Class IIThumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part numberFebruary 17, 2015
Z-1260-2015Class IISynthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intendFebruary 3, 2015
Z-1313-2015Class IISynthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw inserDecember 19, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemMarch 10, 2026
K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemMarch 9, 2026
K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemMarch 2, 2026
K243715Synthes Patient Specific ImplantsNovember 12, 2025
K241927Synthes Graphic Case & Tray SystemMarch 28, 2025
K233994VOLT™ Proximal Humerus 3.5 Plating SystemJuly 26, 2024
K233967DePuy Synthes MatrixSTERNUM Fixation SystemMay 9, 2024
K131792SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAYDecember 16, 2013
K123723SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMSeptember 5, 2013
K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMApril 11, 2013
K122647SYNTHES PATIENT SPECIFIC PLATEFebruary 28, 2013
K113567SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMNovember 19, 2012
K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMAugust 23, 2012
K121574SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMJune 29, 2012
K113071SYNTHECEL DURA REPLACEMENT DEVICESJanuary 9, 2012
K113251SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATESDecember 21, 2011
K110604VBB SYSTEMDecember 13, 2011
K111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSNovember 16, 2011
K112689SYNTHES STERNAL FIXATION SYSTEMOctober 26, 2011
K093772SYNTHES STERNAL FIXATION SYSTEMMarch 29, 2010