Synthes, Inc.
43 recalls on record · Latest: Aug 5, 2020
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Agency notice ledger
Federal filing book Synthes, Inc. MID-BOOK · SINGLE-AGENCY
#411 of 14,151 · 43 notices · 0.041% archive
- BOOK 43 notices
- RANK #411 of 14,151
- SHARE 0.041% archive
- AGENCY FDA Devices (43)
- CAT medical devices
- CATS 1 category
- LATEST Aug 5, 2020
- PHOTO Abbott Medical
Nearest notice-volume peer: Abbott Medical (0 notice gap)
Synthes, Inc. accounts for about 0.041% of the 104,423-notice archive on 43 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Synthes, Inc.'s standing among 14,151 recalling firms
Synthes, Inc. ranks 411th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Synthes, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
43 411th of 14151 higher than 13,739 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Synthes, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Synthes, Inc. (this)
Synthes, Inc.
43 notices
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43 notices
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43 notices
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43 notices
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43 notices
What this shows Synthes, Inc. holds about 0.041% of archive notices alongside 43 distinct filings.
FDA Devices Moderate Aug 5, 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.
FDA Devices Moderate Feb 5, 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.
FDA Devices Moderate Feb 5, 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.
FDA Devices Moderate Feb 5, 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.
FDA Devices Moderate Feb 5, 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.
FDA Devices Moderate Feb 5, 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.
FDA Devices Moderate May 2, 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.
FDA Devices Moderate May 2, 2018
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
FDA Devices Moderate Feb 28, 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
FDA Devices Moderate Jul 22, 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
FDA Devices Moderate Jul 15, 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.
FDA Devices Moderate Jul 8, 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.
FDA Devices Moderate Jun 24, 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.
FDA Devices Moderate Jun 24, 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
FDA Devices Moderate Jun 10, 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.
FDA Devices Moderate May 20, 2015
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Devices Moderate Apr 8, 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.
FDA Devices Moderate Apr 1, 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.
FDA Devices Moderate Mar 25, 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.
FDA Devices Moderate Mar 18, 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, suc
FDA Devices Moderate Feb 18, 2015
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
FDA Devices Moderate Feb 4, 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 unio
FDA Devices Moderate Feb 4, 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.
FDA Devices Moderate Jan 21, 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.
FDA Devices Moderate Nov 26, 2014
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
FDA Devices Moderate Oct 29, 2014
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
FDA Devices Moderate Oct 1, 2014
DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905
FDA Devices Critical Aug 27, 2014
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
FDA Devices Moderate Aug 27, 2014
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
FDA Devices Moderate Jul 30, 2014
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
FDA Devices Moderate Jul 9, 2014
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
FDA Devices Moderate Jun 25, 2014
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
FDA Devices Moderate Jun 18, 2014
Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
FDA Devices Moderate Jun 11, 2014
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
FDA Devices Moderate Jun 4, 2014
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.
FDA Devices Moderate Apr 23, 2014
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
FDA Devices Moderate Apr 23, 2014
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
FDA Devices Moderate Apr 2, 2014
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
FDA Devices Moderate Mar 19, 2014
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placeme
FDA Devices Moderate Mar 12, 2014
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.
FDA Devices Moderate Feb 26, 2014
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
FDA Devices Moderate Feb 26, 2014
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
FDA Devices Moderate Feb 26, 2014
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
Synthes, Inc. holds a measurable archive slice
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (43 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Synthes, Inc.? ▼
PlainRecalls indexes 43 distinct federal recall events naming Synthes, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Synthes, Inc. sit among other recalling firms? ▼
Synthes, Inc. ranks #411 of 14,151 by distinct recall-event count among 14,151 firms in this archive (97th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Synthes, Inc.'s notices? ▼
FDA Devices accounts for 43 of this firm's 43 indexed notices.
What product category dominates Synthes, Inc.'s filing book? ▼
Filings for Synthes, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Synthes, Inc.: 43 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Synthes, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026