Synthes (USA) Products, LLC
Synthes (USA) Products, LLC holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2026, with 164 FDA device recalls on record.
Name variants for Synthes (USA) Products, LLC
as filed with FDA- Synthes (USA) Products, LLC
- Synthes USA Products, LLC
Top product codes for Synthes (USA) Products, LLC
FDA recalls by Synthes (USA) Products, LLC
10 most recent of 164- Z-1702-2026 — 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
- Z-1703-2026 — 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
- Z-0228-2026 — LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
- Z-0229-2026 — LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
- Z-1916-2024 — STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
- Z-1236-2024 — 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
- Z-1242-2024 — Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
- Z-1238-2024 — RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
- Z-1239-2024 — TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
- Z-1235-2024 — 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Synthes (USA) Products, LLC
- K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
- K212943 — SyntheCel Dura Repair
- K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
- K210408 — DePuy Synthes Variable Angle Locking Patella Plating System
- K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
- K201346 — DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
- K192702 — DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
- K201944 — DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
- K201578 — DePuy Synthes Variable Angle Locking Patella Plating System
- K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
- K191463 — DePuy Synthes Hammertoe Continuous Compression Implant
- K192655 — Depuy Synthes Maxillofacial Portfolio - MR Conditional
- K192327 — DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
- K190963 — DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
- K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional
- K183472 — DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional
- K180541 — DePuy Synthes 2.0 mm Quick Insertion Screws
- K180213 — Titanium TomoFix Medial High Tibia Plate Anatomical
- K182154 — Depuy Synthes Femoral Neck System
- K180544 — DePuy Synthes Static Staples
- K170818 — Craniomaxillofacial Distraction System (CMFD)
- K172157 — DePuy Synthes Femoral Recon Nail System
- K170802 — TRAUMACEM V+ Injectable Bone Cement
- K162594 — Craniomaxillofacial Distraction System (CMFD)
- K170654 — USS System
- K161616 — DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
- K153587 — Taps for Resorbable Screws
- K161590 — MatrixRIB Fixation System
- K162358 — T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
- K160167 — DePuy Synthes TFNA Augmentation System
- K150673 — SYNFIX Evolution Secured Spacer System
- K150796 — Dental Bone Cutting Instruments
- K151276 — DePuy Synthes T-PAL Ti Spacer
- K143285 — Mandible External Fixator - MR Conditional
- K150099 — Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
- K142838 — Synapse Occipital-Cervical-Thoracic (OCT) System
- K141165 — MATRIXWAVE MMF SYSTEM
- K141897 — SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
- K141796 — DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
- K130720 — SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
- K141241 — MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
- K140462 — MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
- K133616 — MATRIXRIB FIXATION SYSTEM
- K131548 — SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
- K133698 — SYNAPSE SYSTEM
- K131276 — LATERAL SYNFIX
- K132910 — DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
- K131186 — SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
- K122639 — SYNTHES SYNCAGE EVOLUTION SPACER
- K123180 — FALCON SPACER
- K120807 — SYNTHES MULTILOC HUMERAL NAILING SYSTEM
- K120689 — SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
- K113364 — 2.7MM LCP ULNA OSTEOTOMY SYSTEM
- K112583 — SYNTHES CORTICAL SCREWS
- K111891 — SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
- K112085 — SYNTHES LCP PEDIATRIC PLATE SYSTEMS
- K111437 — SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
- K111230 — SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
- K103822 — SYNTHES HEMOSTATIC BONE PUTTY (HBP)
- K102722 — NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
- K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
Data sourced from openFDA. This site is unofficial and independent of the FDA.