Synthes USA HQ, Inc.

FDA Regulatory Profile

Summary

Total Recalls
56 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0393-2014Class IISynthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer RemOctober 15, 2013
Z-0473-2014Class IISynthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wOctober 9, 2013
Z-0405-2014Class IISynthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-October 8, 2013
Z-0394-2014Class IISynthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattOctober 3, 2013
Z-0202-2014Class IISynthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a noOctober 3, 2013
Z-0369-2014Class IISynthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric FixOctober 3, 2013
Z-0455-2014Class IISynthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height September 30, 2013
Z-0341-2014Class IISynthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the eSeptember 24, 2013
Z-0114-2014Class IISynthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary cAugust 13, 2013
Z-0429-2014Class IISynthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the August 1, 2013
Z-0408-2014Class IISlipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of largeJuly 31, 2013
Z-0380-2014Class II2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotoJuly 31, 2013
Z-0384-2014Class IISynthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw systemJuly 31, 2013
Z-0387-2014Class IILarge Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress CompressionJuly 31, 2013
Z-0388-2014Class IISynthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fractuJuly 31, 2013
Z-0474-2014Class IISynthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) SysteJuly 30, 2013
Z-0407-2014Class IISynthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of hJuly 30, 2013
Z-2087-2013Class IISynthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fiJuly 30, 2013
Z-0409-2014Class IISynthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur July 30, 2013
Z-0410-2014Class IIVertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebrJuly 30, 2013