25 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HWX·February 25, 2026
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HWX·February 25, 2026
TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HSB·January 24, 2024
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HRS·January 24, 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 Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HXX·April 25, 2024
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code JDR·August 30, 2022
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code N/A·January 24, 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 Recall
Open, Classified
·Synthes USA HQ, Inc.·Product code KTT·October 12, 2012
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 Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HSB·January 24, 2024
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HSZ·January 24, 2024
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 Recall
Open, Classified
·Synthes (USA) Products LLC·Product code LXH·December 22, 2021
TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HSB·January 24, 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 Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HTO·January 24, 2024
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code JDR·September 27, 2022
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 Recall
Open, Classified
·Synthes (USA) Products LLC·Product code JDS·September 26, 2025
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 Recall
Open, Classified
·Synthes (USA) Products LLC·Product code JDS·September 26, 2025
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code JDR·September 27, 2022
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code KWI·April 7, 2022
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code JDR·September 27, 2022
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HSB·February 1, 2023