Synthes GmbH
Selzach Solothurn, CH
SYNTHES GMBH appears in FDA device records in Selzach Solothurn, CH. FDA records list 62 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 209 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Synthes GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Synthes Spine510(k), recall
- Synthes U S Arecall
- Synthes USA HQ, Inc.enforcement report, recall
510(k) clearance history
Showing 50 of 62FDA records hold 62 510(k) clearances for Synthes GmbH between 1995 and 2026. The busiest year on record is 2012, with 10. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1998 | 5 |
| 1999 | 3 |
| 2000 | 6 |
| 2001 | 2 |
| 2002 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 4 |
| 2011 | 8 |
| 2012 | 10 |
| 2013 | 4 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254093 | DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System | HRS | Substantially Equivalent | |
| K260069 | DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System | HRS | Substantially Equivalent | |
| K254054 | VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System | HRS | Substantially Equivalent | |
| K243715 | Synthes Patient Specific Implants | GXN | Substantially Equivalent | |
| K241927 | Synthes Graphic Case & Tray System | KCT | Substantially Equivalent | |
| K233994 | VOLT™ Proximal Humerus 3.5 Plating System | HRS | Substantially Equivalent | |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation System | HRS | Substantially Equivalent | |
| K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | GXQ | Substantially Equivalent | |
| K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM | GWO | Substantially Equivalent | |
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K122647 | SYNTHES PATIENT SPECIFIC PLATE | JEY | Substantially Equivalent | |
| K122211 | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS | HAW | Substantially Equivalent | |
| K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | JEY | Substantially Equivalent | |
| K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | MQN | Substantially Equivalent | |
| K120838 | SYNTHES MATRIX SYSTEM | NKB | Substantially Equivalent | |
| K121574 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | JEY | Substantially Equivalent | |
| K111048 | SYNTHES SCOUT TACK FIXATION | OMR | Unknown | |
| K120928 | SYNTHES MATRIX SYSTEM | NKB | Substantially Equivalent | |
| K120571 | SYNTHES USS CONNECTOR | NKB | Substantially Equivalent | |
| K113149 | SYNTHES USS CONNECTORS | MNI | Substantially Equivalent | |
| K113071 | SYNTHECEL DURA REPLACEMENT DEVICES | GXQ | Substantially Equivalent | |
| K113251 | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES | JEY | Substantially Equivalent | |
| K113044 | SYNTHES MIRS | NKB | Substantially Equivalent | |
| K110604 | VBB SYSTEM | NDN | Substantially Equivalent | |
| K111358 | SYNTHES USS | NKB | Substantially Equivalent | |
| K111323 | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS | KKY | Substantially Equivalent | |
| K112689 | SYNTHES STERNAL FIXATION SYSTEM | HRS | Substantially Equivalent | |
| K103558 | SYNTHES SCOUT VESSEL GUARD | OMR | Unknown | |
| K103287 | SYNTHES 6.0 COCR AND CPT TI-3 RODS | NKB | Substantially Equivalent | |
| K093762 | SYNTHES ZERO-P | OVE | Substantially Equivalent | |
| K100952 | MODIFICATION TO SYNTHES MATRIX SYSTEM | NKB | Substantially Equivalent | |
| K100089 | SYNTHES T-PAL SPACER | MAX | Substantially Equivalent | |
| K093772 | SYNTHES STERNAL FIXATION SYSTEM | HRS | Substantially Equivalent | |
| K091159 | SYNTHES ORACLE PLATE | KWQ | Substantially Equivalent | |
| K090549 | SYNTHES SYNAPSE TRANSCONNECTOR | KWP | Substantially Equivalent | |
| K082914 | CLAMPFIX | NKB | Substantially Equivalent | |
| K082572 | USS ILIOSACRAL, USS POLYAXIAL | NKB | Substantially Equivalent | |
| K072791 | ORACLE SPACER, OPAL SPACER | MAX | Substantially Equivalent | |
| K071667 | SYNTHES VECTRA-ONE SYSTEM | KWQ | Substantially Equivalent | |
| K051665 | SYNTHES VECTRA-T SYSTEM | KWQ | Substantially Equivalent | |
| K041389 | SYNTHES CONTOURED SYNMESH SPACER | MQP | Substantially Equivalent | |
| K032534 | SYNTHES AFS | NQW | Substantially Equivalent | |
| K013072 | CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) | MQV | Substantially Equivalent | |
| K020602 | SYNTHES PILON PLATE | HRS | Substantially Equivalent | |
| K020244 | SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) | KWQ | Substantially Equivalent | |
| K010108 | USS-LINE EXTENSION | MNI | Substantially Equivalent | |
| K003836 | SYNTHES SYNEX SPACER SYSTEM | MQP | Substantially Equivalent | |
| K003061 | SYNTHES USS (10.0MM SIDE OPENING SCREWS) | KWQ | Substantially Equivalent | |
| K001864 | SYNTHES CERVIFIX SYSTEM | KWQ | Substantially Equivalent | |
| K000742 | SYNTHES ANTERIOR CSLP SYSTEM | KWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009417901 | 3009417901 | SYNTHES GMBH | Luzernstrasse 21, Zuchwil Solothurn CH-4528 CH | 2026 | and 156 more, listed in full below |
| 3000270450 | 3000270450 | Synthes GMBH | Industriestrasse 28, Selzach Solothurn 2545 Selz. CH | 2026 | and 80 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HSTApparatus, Traction, Non-Powered
- HRXArthroscope
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- EQJBur, Ear, Nose And Throat
- GFFBur, Surgical, General & Plastic Surgery
- GEACannula, Surgical, General & Plastic Surgery
- GBXCatheter, Irrigation
- EMLChisel, Bone, Surgical
- FZOChisel, Surgical, Manual
- GDJClamp, Surgical, General & Plastic Surgery
- GXRCover, Burr Hole
- FZTCutter, Surgical
- GDIDissector, Surgical, General & Plastic Surgery
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- GFCDriver, Surgical, Pin
- DZJDriver, Wire, And Bone Drill, Manual
- GXQDura Substitute
- GXZElectrode, Needle
- HBWFastener, Plate, Cranioplasty
- GENForceps, General & Plastic Surgery
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDZHandle, Scalpel
- GDGHook, Surgical, General & Plastic Surgery
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- FQPLamp, Operating-Room
- FTMMesh, Surgical
- EZXMesh, Surgical, Metal
- FTLMesh, Surgical, Polymeric
- GXPMethyl Methacrylate For Cranioplasty
- HBCMotor, Drill, Electric
- HBBMotor, Drill, Pneumatic
- GEYMotor, Surgical Instrument, Ac-Powered
- GAANeedle, Aspiration And Injection, Disposable
- HAWNeurological Stereotaxic Instrument
- GFIOsteotome, Manual
- GWOPlate, Cranioplasty, Preformed, Alterable
- GXNPlate, Cranioplasty, Preformed, Non-Alterable
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- GADRetractor
- FDGRetractor, Fiberoptic
- GZTRetractor, Self-Retaining, For Neurosurgery
- HSBRod, Fixation, Intramedullary And Accessories
- HSOSaw
- DZLScrew, Fixation, Intraosseous
- GXLScrewdriver, Skullplate
- ETNStimulator, Nerve
- GAHStylet, Surgical, General & Plastic Surgery
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- FMFSyringe, Piston
- FTYTape, Measuring, Rulers And Calipers
- FSMTray, Surgical, Instrument
Recall records
Showing 25 of 209| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2698-2020 | MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin. | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw. | Class II | Terminated | |
| Z-0883-2020 | 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field. | Class II | Terminated | |
| Z-0882-2020 | 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field. | Class II | Terminated | |
| Z-0881-2020 | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field. | Class II | Terminated | |
| Z-0880-2020 | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field. | Class II | Terminated | |
| Z-0879-2020 | 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field. | Class II | Terminated | |
| Z-1514-2018 | Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants. | There is a potential for the connection screw of the stem extractor to break. | Class II | Terminated | |
| Z-1511-2018 | Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters. | Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts. | Class II | Terminated | |
| Z-0669-2018 | LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments | May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening. | Class II | Terminated | |
| Z-2051-2015 | TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions. | A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection. | Class II | Terminated | |
| Z-2092-2015 | Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended 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 | It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide. | Class II | Terminated | |
| Z-1799-2015 | Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2 - 4), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw. | Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage. | Class II | Terminated | |
| Z-1915-2015 | DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions. | certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components). | Class II | Terminated | |
| Z-1711-2015 | 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot. | affected parts and lots of the Cannulated Drill Bits have the potential to break during use | Class II | Terminated | |
| Z-1800-2015 | 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone. | Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly. | Class II | Terminated | |
| Z-1600-2015 | TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma. | TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay. | Class II | Terminated | |
| Z-1352-2015 | Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. | The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments. | Class II | Terminated | |
| Z-1281-2015 | Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX. | For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correct material of heat-treated 304 Stainless Steel. This may lead to stress-corrosion cracking, which can lead to surgical delay or unintended debris entering the surgical site. | Class II | Terminated | |
| Z-1260-2015 | Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate. | The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN. | Class II | Terminated | |
| Z-1313-2015 | Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery. | In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged. | Class II | Terminated | |
| Z-1021-2015 | 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates. | Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located. | Class II | Terminated | |
| Z-0973-2015 | Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System. | Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection. | Class II | Terminated | |
| Z-0219-2015 | 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur | The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion. | Class II | Terminated | |
| Z-1009-2015 | The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 03.305.500 03.305.500S Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects. | Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe. | Class II | Terminated | |
| Z-0092-2015 | DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715 | Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain