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Synthes (usa) Products Llc Recalls

92 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Synthes (usa) Products Llc.

92Total Recalls
1Critical
122.5MUnits Affected
Feb 25, 2026Most Recent
All Recalls

Every Synthes (usa) Products Llc Recall

Sorted by most recent. Click any recall for full details.

92 recalls
High RiskFDA
Synthes (usa) Products Llc
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Medical Devices·77 affected·Feb 25, 2026
High RiskFDA
Synthes (usa) Products Llc
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral N...
Medical Devices·120 affected·Sep 26, 2025
High RiskFDA
Synthes (usa) Products Llc
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic s...
Medical Implants·261 affected·Apr 25, 2024
High RiskFDA
Synthes (usa) Products Llc
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Medical Devices·30 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacia...
Medical Devices·10 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe f...
Medical Devices·5 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number:...
Medical Devices·11 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Surgical Devices·17 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
Medical Devices·47 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Surgical Devices·30 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur...
Medical Devices·6 affected·Feb 1, 2023
High RiskFDA
Synthes (usa) Products Llc
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur...
Medical Devices·5 affected·Feb 1, 2023
High RiskFDA
Synthes (usa) Products Llc
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Medical Implants·96 affected·Sep 27, 2022
High RiskFDA
Synthes (usa) Products Llc
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, ...
Medical Implants·0 affected·Apr 7, 2022
High RiskFDA
Synthes (usa) Products Llc
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" T...
Medical Devices·600 affected·Dec 22, 2021
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Surgical Devices·1,566 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Surgical Devices·1,231 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
Surgical Devices·748 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
Surgical Devices·1,447 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
Surgical Devices·651 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
Surgical Devices·531 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
Surgical Devices·1,337 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
Surgical Devices·1,142 affected·Nov 19, 2020
RecallFDA
Synthes (usa) Products Llc
END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body replacement device for...
Medical Implants·4 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for...
Medical Implants·4 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical,...
Medical Implants·5 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic...
Medical Implants·7 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic ...
Medical Implants·23 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, ...
Medical Implants·18 affected·Sep 21, 2020
RecallFDA
Synthes (usa) Products Llc
SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, tho...
Medical Implants·12 affected·Sep 21, 2020
High RiskFDA
Synthes (usa) Products Llc
MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm ...
Medical Devices·9 affected·Sep 5, 2019
High RiskFDA
Synthes (usa) Products Llc
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intend...
Medical Devices·20 affected·Sep 12, 2018
High RiskFDA
Synthes (usa) Products Llc
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Medical Devices·50 affected·May 4, 2018
High RiskFDA
Synthes (usa) Products Llc
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Medical Devices·235 affected·Apr 2, 2018
High RiskFDA
Synthes (usa) Products Llc
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Medical Devices·196 affected·Apr 2, 2018
High RiskFDA
Synthes (usa) Products Llc
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Medical Devices·4 affected·Mar 5, 2018
High RiskFDA
Synthes (usa) Products Llc
Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
Medical Devices·3 affected·Mar 5, 2018
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·6,257 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic ...
Medical Devices·6 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·1,144 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Medical Devices·4 affected·Jul 21, 2017
High RiskFDA
Synthes (usa) Products Llc
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the ...
Surgical Devices·2 affected·Jan 31, 2017
High RiskFDA
Synthes (usa) Products Llc
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Medical Implants·31 affected·Nov 29, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Medical Devices·84 affected·Nov 1, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in ...
Surgical Devices·198 affected·Oct 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Extraction Hook - Sterile for TI Cannulated Nails
Medical Devices·114 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Medical Devices·319 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
3.0 mm Reaming Rod/950 mm, Sterile
Medical Devices·887 affected·Oct 3, 2016