FDA Device Recalls

Recalls / Firms / Synthes (USA) Products LLC

Synthes (USA) Products LLC

164 FDA device recalls on record.

DateClassProductReason
2026-02-252.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
2026-02-252.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
2025-09-26LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in
2025-09-26LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in
2024-04-25STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing o
2024-01-24RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconst
2024-01-241.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part
2024-01-24RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-2
2024-01-24TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of pro
2024-01-24VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part
2024-01-24TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of pr
2024-01-2413 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotaloca
2024-01-24Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part
2024-01-242.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment
2023-02-01TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixatio
2023-02-01TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixatio
2023-02-01TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixatio
2022-09-27DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
2022-09-27SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes S
2022-09-27SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
2022-09-27SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
2022-08-30Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
2022-04-07Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial h
2021-12-22Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument av
2020-11-19DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code
2020-11-19DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code
2020-11-19DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-11-19DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code:
2020-09-21END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a v
2020-09-21END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replaceme
2020-09-21END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replaceme
2020-09-21SYNMESH 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body r
2020-09-21END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replaceme
2020-09-21END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a v
2020-09-21END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a v
2020-09-21SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body r
2020-09-21SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body repl
2020-09-21SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body repl
2020-09-213.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body r
2020-09-21END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a v
2020-09-21STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacem
2020-09-21DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a verteb
2020-09-21STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replace
2020-07-21DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intende
2019-09-16Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
2019-09-05MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm
2018-09-123.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Hea
2018-05-04Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for
2018-04-02Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
2018-04-02Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
2018-03-05Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
2018-03-05Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
2018-03-05Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
2017-07-26Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for gu
2017-07-262.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended
2017-07-262.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for
2017-07-262.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for
2017-07-262.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for
2017-07-263.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are
2017-07-262.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods ar
2017-07-2111MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
2017-01-31PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.35
2016-12-29Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: In
2016-11-29Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
2016-11-01Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
2016-10-31Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for
2016-10-032.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
2016-10-032.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
2016-10-033.0 mm Reaming Rod/950 mm, Sterile
2016-10-032.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
2016-10-033.0 mm Guide Rod/950 mm with Smooth Tip, sterile
2016-10-033.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
2016-10-032.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
2016-10-03Extraction Hook - Sterile for TI Cannulated Nails
2016-06-28Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titaniu
2016-06-07Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical
2016-05-31Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Produc
2016-05-31Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27
2016-05-31Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/20
2016-05-31Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/
2016-05-31Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
2016-05-31Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 442
2016-05-31Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 44
2016-05-31Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2
2016-05-31Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, m
2016-05-31Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2
2016-05-31Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839,
2016-05-31Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 470
2016-05-23TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vecto
2016-05-23TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distr
2016-05-23TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vecto
2016-05-23TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector
2016-05-23TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector
2016-05-23TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Dist
2016-05-11Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of t
2016-05-11Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of th
2016-05-11Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of th
2016-05-02DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part num
2016-05-02LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies,
2016-05-021.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation Syst
2016-05-021.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation Syst
2016-05-021.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation Syst
2016-04-183.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Thr
2016-04-183.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm
2016-04-045.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated f
2016-02-23Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage
2016-02-23Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage
2016-02-18Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL S
2016-02-166.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Prod
2016-02-164.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixatio
2016-02-167.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation
2016-02-164.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bo
2016-02-16Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
2016-02-163.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation
2016-02-166.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Prod
2016-02-164.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product
2016-01-06Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 966
2015-12-08SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Devic
2015-12-08SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Devic
2015-12-08SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Devic
2015-12-08SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Devic
2015-12-08SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Devic
2015-12-01SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orth
2015-11-022.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteo
2015-11-02Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-A
2015-10-19Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondar
2015-10-08Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0m
2015-10-07Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Pl
2015-10-062.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP
2015-09-28Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5M
2015-09-21Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head
2015-09-14Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming
2015-09-045.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit
2015-09-03Inserter for Titanium Elastic Nails (TEN), orthopedic device
2015-08-31Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube C
2015-08-11Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in lo
2015-07-29VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib support
2015-07-29Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended
2015-07-29Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor an
2015-07-22Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary
2015-07-01Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nai
2015-07-018.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrume
2015-06-24Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent M
2015-06-2416mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation S
2015-06-10Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head e
2014-11-06Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed fo
2014-10-23Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial R
2013-10-14Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve
2013-07-30Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and r
2013-05-31Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Syn
2012-05-31Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT