25 results
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32ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
FDA Enforcement
Class II
·Ongoing·Synthes USA HQ, Inc.·August 7, 2013
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·February 16, 2022
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·October 12, 2022
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·October 26, 2022
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·October 26, 2022
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 22, 2023