Synthes (USA) Products LLC

FDA Regulatory Profile

Summary

Total Recalls
162 (1 Class I)
510(k) Clearances
44
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0228-2026Class IILOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used iSeptember 26, 2025
Z-0229-2026Class IILOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used iSeptember 26, 2025
Z-1916-2024Class IISTARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing oApril 25, 2024
Z-1239-2024Class IITFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of prJanuary 24, 2024
Z-1238-2024Class IIRAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstJanuary 24, 2024
Z-1241-2024Class IIVA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. PartJanuary 24, 2024
Z-1237-2024Class IIRIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-2January 24, 2024
Z-1236-2024Class II2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachmentJanuary 24, 2024
Z-1235-2024Class II1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment PartJanuary 24, 2024
Z-1240-2024Class IITFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of pJanuary 24, 2024
Z-1242-2024Class IIOpal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease ParJanuary 24, 2024
Z-1234-2024Class II13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocaJanuary 24, 2024
Z-1246-2023Class IITFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixatioFebruary 1, 2023
Z-1248-2023Class IITFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixatioFebruary 1, 2023
Z-1247-2023Class IITFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixatioFebruary 1, 2023
Z-0100-2023Class IISPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910September 27, 2022
Z-0101-2023Class IIDePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001September 27, 2022
Z-0099-2023Class IISPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512September 27, 2022
Z-0098-2023Class IISPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SSeptember 27, 2022
Z-0008-2023Class IIHammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001August 30, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K212943SyntheCel Dura RepairJanuary 28, 2022
K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)May 25, 2021
K210408DePuy Synthes Variable Angle Locking Patella Plating SystemApril 8, 2021
K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemMarch 26, 2021
K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary NaSeptember 23, 2020
K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSeptember 18, 2020
K201944DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)September 10, 2020
K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSeptember 9, 2020
K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSeptember 3, 2020
K191463DePuy Synthes Hammertoe Continuous Compression ImplantFebruary 26, 2020
K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalDecember 30, 2019
K192327DePuy Synthes 2.4mm LCP Straight Wrist Plate, SterileNovember 7, 2019
K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalJuly 23, 2019
K183472DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR ConditionalMarch 13, 2019
K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalMarch 13, 2019
K180213Titanium TomoFix Medial High Tibia Plate AnatomicalOctober 19, 2018
K182154Depuy Synthes Femoral Neck SystemOctober 16, 2018
K180544DePuy Synthes Static StaplesJuly 24, 2018
K172157DePuy Synthes Femoral Recon Nail SystemNovember 14, 2017
K170802TRAUMACEM™ V+ Injectable Bone CementSeptember 28, 2017