Synthes
FDA adverse event reports naming Synthes as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SYNTHES.
- Total reports
- 1,773
- Deaths
- 8
- Injuries
- 1,041
- Malfunctions
- 661
Reports per year
Source: FDA adverse event reports by year received, 2009–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Plate, Fixation, BoneHRS364
- Screw, Fixation, BoneHWC232
- Rod, Fixation, Intramedullary And AccessoriesHSB143
- Bit, DrillHTW108
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT93
- Appliance, Fixation, Spinal Intervertebral BodyKWQ93
- Prosthesis, Intervertebral DiscMJO76
- Plate, BoneJEY54
- Appliance, Fixation, Spinal InterlaminalKWP53
- ReamerHTO48
Recent recalls
- 2026-03-30Open, ClassifiedProcess change control
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
- 2026-03-30Open, ClassifiedProcess change control
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
- 2025-10-21Open, ClassifiedProcess control
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.
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
- 2025-10-21Open, ClassifiedProcess control
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.
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
- 2024-05-28Open, ClassifiedProcess change control
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
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
- 2024-03-01Open, ClassifiedProcess control
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
Products not sterilized, sterility cannot be confirmed
- 2024-03-01Open, ClassifiedProcess control
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Products not sterilized, sterility cannot be confirmed
- 2024-03-01Open, ClassifiedProcess control
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Products not sterilized, sterility cannot be confirmed
- 2024-03-01Open, ClassifiedProcess control
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
Products not sterilized, sterility cannot be confirmed
- 2024-03-01Open, ClassifiedProcess control
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
Products not sterilized, sterility cannot be confirmed
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