148 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·April 8, 2026
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·April 8, 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.
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·October 29, 2025
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.
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·October 29, 2025
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 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
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 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
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·June 5, 2024
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis. Part Number: 314.746S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 6, 2019
Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 1, 2012
Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·July 20, 2016
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·July 20, 2016
7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·July 20, 2016
Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·July 20, 2016