The Recall Desk

Manufacturer

Synthes, Inc.

43 recalls in our database name Synthes, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
43
Critical
0
Severe
1
Most recent
2020-08-05

Of the 43 recalls from Synthes, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 43

  • ModerateFDA (Devices)·Z-2698-2020·2020-08-05

    Synthes Recalls MatrixNEURO Screws Due to Incorrect Body Clip Labeling

    Synthes, Inc. is recalling 104 units of MatrixNEURO 5mm screws because the body clip is etched with '4', incorrectly indicating a 4mm screw, despite correct outer packaging.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0882-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open or fail to separate, potentially delaying surgery.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0879-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw accessible, potentially delaying surgery.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0883-2020·2020-02-05

    Synthes 2.4mm Sterile Locking Screw Recall Due to Packaging Defect

    Synthes is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open prematurely, potentially preventing the screw from being used during surgery.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the inner cap may open or the tube may remain in the outer cap, preventing screw removal.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0880-2020·2020-02-05

    Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

    Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw sealed, potentially causing surgical delays.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2018·2018-05-02

    Synthes Stem Extractor Recalled Due to Potential Screw Breakage

    Synthes, Inc. is recalling 31 Stem Extractor f/Guide Bar units because the connection screw may break during use.

    Product
    Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1511-2018·2018-05-02

    Synthes Flex Arm Recalled for Potential Connection Failure

    Synthes, Inc. is recalling 84 Flex Arm units because the quick connect feature may fail to connect to mating parts.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2018·2018-02-28

    Synthes LCP Drill Sleeve Recall Due to Connection and Alignment Issues

    Synthes, Inc. is recalling LCP Drill Sleeve 1.5 Drill Bits because they may fail to attach to plates, potentially causing surgical delays or off-center drilling.

    Product
    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
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2092-2015·2015-07-22

    Synthes Recalls RIA Drive Shafts and Reamer Heads Due to Breakage Risk

    Synthes, Inc. is recalling Reamer / Irrigator / Aspirator (RIA) components because they may break if incorrectly assembled or used improperly.

    Product
    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 imp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2015·2015-07-15

    Synthes Recalls Three Titanium Tibial Nail End Caps for Missing Inspection

    Synthes is recalling three units of a titanium end cap for tibial nails because they were shipped before a required internal inspection was completed.

    Product
    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 fra
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1915-2015·2015-07-08

    DePuy Synthes Titanium Recon Screws Recalled for Incorrect Insert

    Synthes, Inc. is recalling 276 DePuy Synthes 6.5 mm Titanium Recon Screws because certain lots contain the wrong insert.

    Product
    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 patholo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2015·2015-06-24

    Synthes Pull Reduction Device Recalled for Potential Intraoperative Breakage

    Synthes, Inc. is recalling Pull Reduction Devices for 4.3mm Percutaneous Drill Guides because incorrect hardness specifications may cause the devices to break during surgery.

    Product
    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 (approx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2015·2015-06-24

    Synthes Recalls 3.7mm Cannulated Screws Due to Incorrect Labeling

    Synthes, Inc. is recalling 54 units of 3.7mm Cannulated Locking and Conical Screws because certain lots were found to have been labeled incorrectly.

    Product
    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 bon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1711-2015·2015-06-10

    Synthes Cannulated Drill Bits Recalled for Potential Breakage During Use

    Synthes, Inc. is recalling specific lots of Cannulated Drill Bits because they have the potential to break during use. The affected devices were distributed in the US and Canada.

    Product
    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 wa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1600-2015·2015-05-20

    Synthes Recalls TFNA Proximal Femoral Nails Due to Locking Mechanism Defect

    Synthes, Inc. is recalling 8,175 TFNA Proximal Femoral Nails because the locking mechanism was assembled too close to the top, potentially causing surgical delays.

    Product
    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1352-2015·2015-04-08

    Synthes Aiming Arms Recalled Due to Potential Jamming of Guide Sleeve

    Synthes, Inc. is recalling 131 Aiming Arms from the TFN-ADVANCED system because the guide sleeve may jam, potentially delaying instrument removal.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2015·2015-04-01

    Synthes Electric Pen Drive Hand Switch Labeling Error Recall

    Synthes, Inc. is recalling 249 Electric Pen Drive systems because the Hand Switch labels for 'on' and 'lock' were interchanged.

    Product
    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, b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2015·2015-03-25

    Synthes Thumb Screws Recalled Due to Incorrect Stainless Steel Material

    Synthes, Inc. is recalling 183 thumb screws for orthopedic aiming arms because incorrect raw material was used, which may lead to stress-corrosion cracking.

    Product
    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 R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2015·2015-03-18

    Synthes Inserter for Titanium Elastic Nails Recalled for Mechanical Failure

    Synthes, Inc. is recalling Inserter for Titanium Elastic Nails due to potential mechanical failures including shaft breakage and chuck malfunction.

    Product
    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-statu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1094-2015·2015-02-18

    Synthes Recalls Hemostatic Bone Putty Due to Incorrect Brochure Revision

    Synthes, Inc. is recalling 38 units of Hemostatic Bone Putty because Revision A of the brochure was distributed instead of the corrected Revision B.

    Product
    Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1009-2015·2015-02-04

    Synthes Mandible External Fixator Recalled for Incorrect MR Safe Labeling

    Synthes, Inc. is recalling Mandible External Fixators because updated testing protocols mean the devices can no longer be designated MR Safe, despite previous labeling.

    Product
    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
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1021-2015·2015-02-04

    Synthes 2.0 Mandible Locking Plate Bender Recall for Tip Breakage

    Synthes, Inc. is recalling 973 units of the 2.0 Mandible Locking Plate Bender/Cutter because the tips may break during use, potentially delaying surgery.

    Product
    2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0973-2015·2015-01-21

    Synthes Malleable C-Retractor Recalled Due to Potential Spring Corrosion

    Synthes, Inc. is recalling Malleable C-Retractors because the internal spring may corrode or fail, potentially transferring particles to patients and causing adverse tissue reactions or infection.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2015·2014-11-26

    Synthes Recalls Titanium Trochanteric Fixation Nails Due to Assembly Error

    Synthes, Inc. is recalling six sterile titanium trochanteric fixation nails due to incorrect assembly that may compromise bone stability.

    Product
    10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
    Category
    Medical Device
    Distribution
    5 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Synthes

company

Country
Switzerland
Founded
1954
Parent company
Johnson & Johnson

Official website

Source: Wikidata (Q503072), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.