Synthes, Inc.
FDA Regulatory Profile
Synthes, Inc. appears in FDA public data with 43 recalls — including 1 Class I (most serious) —, 26 510(k) clearances, 7 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2698-2020, Class II) was initiated on June 18, 2020. Its most recent 510(k) clearance was granted on March 10, 2026.
Summary
- Total Recalls
- 43 (1 Class I)
- 510(k) Clearances
- 26
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2698-2020 | Class II | MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones | June 18, 2020 |
| Z-0881-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile T | December 16, 2019 |
| Z-0883-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile T | December 16, 2019 |
| Z-0880-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile T | December 16, 2019 |
| Z-0882-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile T | December 16, 2019 |
| Z-0879-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile T | December 16, 2019 |
| Z-1514-2018 | Class II | Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of | March 19, 2018 |
| Z-1511-2018 | Class II | Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Su | March 5, 2018 |
| Z-0669-2018 | Class II | LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment Sy | August 7, 2017 |
| Z-2051-2015 | Class II | TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibi | June 3, 2015 |
| Z-2092-2015 | Class II | Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Hea | May 28, 2015 |
| Z-1799-2015 | Class II | Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupl | May 28, 2015 |
| Z-1915-2015 | Class II | DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105 | May 27, 2015 |
| Z-1800-2015 | Class II | 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are in | May 13, 2015 |
| Z-1711-2015 | Class II | 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Dril | May 13, 2015 |
| Z-1600-2015 | Class II | TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and t | April 9, 2015 |
| Z-1352-2015 | Class II | Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Ai | February 24, 2015 |
| Z-1281-2015 | Class II | Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number | February 17, 2015 |
| Z-1260-2015 | Class II | Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intend | February 3, 2015 |
| Z-1313-2015 | Class II | Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw inser | December 19, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | March 10, 2026 |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | March 9, 2026 |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | March 2, 2026 |
| K243715 | Synthes Patient Specific Implants | November 12, 2025 |
| K241927 | Synthes Graphic Case & Tray System | March 28, 2025 |
| K233994 | VOLT Proximal Humerus 3.5 Plating System | July 26, 2024 |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation System | May 9, 2024 |
| K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | December 16, 2013 |
| K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM | September 5, 2013 |
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM | April 11, 2013 |
| K122647 | SYNTHES PATIENT SPECIFIC PLATE | February 28, 2013 |
| K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | November 19, 2012 |
| K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | August 23, 2012 |
| K121574 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | June 29, 2012 |
| K113071 | SYNTHECEL DURA REPLACEMENT DEVICES | January 9, 2012 |
| K113251 | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES | December 21, 2011 |
| K110604 | VBB SYSTEM | December 13, 2011 |
| K111323 | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS | November 16, 2011 |
| K112689 | SYNTHES STERNAL FIXATION SYSTEM | October 26, 2011 |
| K093772 | SYNTHES STERNAL FIXATION SYSTEM | March 29, 2010 |