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Synthes (USA) Products LLC

93 FDA 510(k) clearances · Recalling firm

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◉ Watch Synthes (USA) Products LLC

RecordFirmDate
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. recall (Z-1702-2026)Synthes (USA) Products LLC2026-03-30
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. recall (Z-1703-2026)Synthes (USA) Products LLC2026-03-30
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. recall (Z-0228-2026)Synthes (USA) Products LLC2025-10-21
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. recall (Z-0229-2026)Synthes (USA) Products LLC2025-10-21
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or recall (Z-1916-2024)Synthes (USA) Products LLC2024-05-28
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate t recall (Z-1234-2024)Synthes (USA) Products LLC2024-03-01
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attach recall (Z-1235-2024)Synthes (USA) Products LLC2024-03-01
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/ recall (Z-1236-2024)Synthes (USA) Products LLC2024-03-01
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolesce recall (Z-1237-2024)Synthes (USA) Products LLC2024-03-01
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair a recall (Z-1238-2024)Synthes (USA) Products LLC2024-03-01
TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilizati recall (Z-1239-2024)Synthes (USA) Products LLC2024-03-01
TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilizat recall (Z-1240-2024)Synthes (USA) Products LLC2024-03-01
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragme recall (Z-1241-2024)Synthes (USA) Products LLC2024-03-01
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine di recall (Z-1242-2024)Synthes (USA) Products LLC2024-03-01
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary recall (Z-1246-2023)Synthes (USA) Products LLC2023-03-10
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporar recall (Z-1247-2023)Synthes (USA) Products LLC2023-03-10
TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary recall (Z-1248-2023)Synthes (USA) Products LLC2023-03-10
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy recall (Z-0098-2023)Synthes (USA) Products LLC2022-10-18
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 recall (Z-0099-2023)Synthes (USA) Products LLC2022-10-18
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 recall (Z-0100-2023)Synthes (USA) Products LLC2022-10-18
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 recall (Z-0101-2023)Synthes (USA) Products LLC2022-10-18
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 recall (Z-0008-2023)Synthes (USA) Products LLC2022-10-06
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers recall (Z-1383-2017)Synthes (USA) Products LLC2017-02-27
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument recall (Z-0867-2017)Synthes (USA) Products LLC2016-12-21
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile recall (Z-0681-2017)Synthes (USA) Products LLC2016-12-01
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are inte recall (Z-0656-2017)Synthes (USA) Products LLC2016-11-23
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile recall (Z-0637-2017)Synthes (USA) Products LLC2016-11-19
3.0 mm Reaming Rod/950 mm, Sterile recall (Z-0638-2017)Synthes (USA) Products LLC2016-11-19
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile recall (Z-0639-2017)Synthes (USA) Products LLC2016-11-19
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile recall (Z-0640-2017)Synthes (USA) Products LLC2016-11-19
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile recall (Z-0641-2017)Synthes (USA) Products LLC2016-11-19
Extraction Hook - Sterile for TI Cannulated Nails recall (Z-0642-2017)Synthes (USA) Products LLC2016-11-19
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile recall (Z-0643-2017)Synthes (USA) Products LLC2016-11-19
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile recall (Z-0644-2017)Synthes (USA) Products LLC2016-11-19
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4 recall (Z-2389-2016)Synthes (USA) Products LLC2016-08-11
Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, recall (Z-2214-2016)Synthes (USA) Products LLC2016-07-15
Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR recall (Z-2189-2016)Synthes (USA) Products LLC2016-07-12
Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374 recall (Z-2190-2016)Synthes (USA) Products LLC2016-07-12
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, recall (Z-2191-2016)Synthes (USA) Products LLC2016-07-12
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & U recall (Z-2192-2016)Synthes (USA) Products LLC2016-07-12
Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 441513 recall (Z-2193-2016)Synthes (USA) Products LLC2016-07-12
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4 recall (Z-2194-2016)Synthes (USA) Products LLC2016-07-12
Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mf recall (Z-2195-2016)Synthes (USA) Products LLC2016-07-12
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 45 recall (Z-2196-2016)Synthes (USA) Products LLC2016-07-12
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 43 recall (Z-2197-2016)Synthes (USA) Products LLC2016-07-12
Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mf recall (Z-2198-2016)Synthes (USA) Products LLC2016-07-12
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/20 recall (Z-2199-2016)Synthes (USA) Products LLC2016-07-12
6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation recall (Z-2152-2016)Synthes (USA) Products LLC2016-07-11
6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation recall (Z-2153-2016)Synthes (USA) Products LLC2016-07-11
7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate recall (Z-2154-2016)Synthes (USA) Products LLC2016-07-11
4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, F recall (Z-2155-2016)Synthes (USA) Products LLC2016-07-11
4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone recall (Z-2156-2016)Synthes (USA) Products LLC2016-07-11
4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Scre recall (Z-2157-2016)Synthes (USA) Products LLC2016-07-11
3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw recall (Z-2158-2016)Synthes (USA) Products LLC2016-07-11
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue recall (Z-2138-2016)Synthes (USA) Products LLC2016-07-07
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, ost recall (Z-1949-2016)Synthes (USA) Products LLC2016-06-10
Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or def recall (Z-1942-2016)Synthes (USA) Products LLC2016-06-09
Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or def recall (Z-1943-2016)Synthes (USA) Products LLC2016-06-09
Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or de recall (Z-1944-2016)Synthes (USA) Products LLC2016-06-09
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fix recall (Z-1918-2016)Synthes (USA) Products LLC2016-06-07
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fix recall (Z-1919-2016)Synthes (USA) Products LLC2016-06-07
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fix recall (Z-1920-2016)Synthes (USA) Products LLC2016-06-07
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. recall (Z-1912-2016)Synthes (USA) Products LLC2016-06-06
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The recall (Z-1709-2016)Synthes (USA) Products LLC2016-05-23
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3 recall (Z-1710-2016)Synthes (USA) Products LLC2016-05-23
Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm recall (Z-1524-2016)Synthes (USA) Products LLC2016-04-20
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Prod recall (Z-1326-2016)Synthes (USA) Products LLC2016-04-05
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Prod recall (Z-1327-2016)Synthes (USA) Products LLC2016-04-05
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Se recall (Z-0585-2016)Synthes (USA) Products LLC2016-01-05
Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile recall (Z-0375-2016)Synthes (USA) Products LLC2015-12-04
Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or recall (Z-0276-2016)Synthes (USA) Products LLC2015-11-14
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6H recall (Z-0236-2016)Synthes (USA) Products LLC2015-11-06
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Frag recall (Z-0167-2016)Synthes (USA) Products LLC2015-10-30
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5. recall (Z-0134-2016)Synthes (USA) Products LLC2015-10-17
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure recall (Z-0126-2016)Synthes (USA) Products LLC2015-10-15
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticul recall (Z-0024-2016)Synthes (USA) Products LLC2015-10-05
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Fla recall (Z-2811-2015)Synthes (USA) Products LLC2015-09-23
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for recall (Z-2794-2015)Synthes (USA) Products LLC2015-09-18
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal r recall (Z-2488-2015)Synthes (USA) Products LLC2015-08-31
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or recall (Z-2475-2015)Synthes (USA) Products LLC2015-08-27
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S recall (Z-2451-2015)Synthes (USA) Products LLC2015-08-24
Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nail recall (Z-2425-2015)Synthes (USA) Products LLC2015-08-20
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Re recall (Z-2418-2015)Synthes (USA) Products LLC2015-08-19
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgica recall (Z-2359-2015)Synthes (USA) Products LLC2015-08-10
Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix recall (Z-2272-2015)Synthes (USA) Products LLC2015-07-28
16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Pres recall (Z-2086-2015)Synthes (USA) Products LLC2015-07-16
Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure recall (Z-2091-2015)Synthes (USA) Products LLC2015-07-16
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is d recall (Z-0931-2015)Synthes (USA) Products LLC2015-01-07
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium P recall (Z-0226-2015)Synthes (USA) Products LLC2014-11-26
Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomie recall (Z-0406-2014)Synthes (USA) Products LLC2013-11-27
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection recall (Z-0404-2014)Synthes (USA) Products LLC2013-11-26
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, recall (Z-2057-2013)Synthes (USA) Products LLC2013-08-26
Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non ste recall (Z-2054-2012)Synthes (USA) Products LLC2012-07-20

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Every clearance here is in the API, with alerts when new ones post.