The Recall Desk

Manufacturer

Synthes (USA) Products LLC

164 recalls in our database name Synthes (USA) Products LLC as the manufacturing or recalling firm.

What the numbers show

Total
164
Critical
0
Severe
22
Most recent
2026-04-08

Of the 164 recalls from Synthes (USA) Products LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 22 (13%) 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.

51–75 of 164

  • LowFDA (Devices)·Z-0405-2021·2020-11-11

    Synthes SYN MESH Vertebral Body Replacement Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 17 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'

    Product
    SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0417-2021·2020-11-11

    Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 18 units of SynMesh Cages due to incorrect statutory labeling. The devices were distributed only in Japan.

    Product
    3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suit
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0403-2021·2020-11-11

    DePuy Synthes SYNMESH CAGE System Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 10 units of DePuy Synthes SYNMESH CAGE System devices distributed in Japan due to incorrect statutory labeling.

    Product
    DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0415-2021·2020-11-11

    Synthes Vertebral Body Replacement Device Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 7 units of the Standard Ring 17mm x 22mm (Ti) vertebral body replacement device due to an incorrect statutory label.

    Product
    STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to th
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0413-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a general medical device.

    Product
    END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration th
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0409-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 18 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of a 'specially controlled medical device.'

    Product
    END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2816-2020·2020-08-26

    DePuy Synthes LCP Plate Recall Due to Dimensional Tolerance Issues

    Synthes (USA) Products LLC is recalling 191 units of DePuy Synthes Trauma LCP One-Third Tubular Plates because dimensional features may be out of tolerance, potentially reducing locking strength.

    Product
    DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0349-2020·2019-11-20

    Synthes Trial Spacers Recalled for Modified Manufacturing Process

    Synthes (USA) Products LLC is recalling nine trial spacers with T-handles because they were modified outside of the approved manufacturing process.

    Product
    MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Hand
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0223-2020·2019-11-06

    Synthes Spinal Screws Recalled Due to Incorrect Diameter

    Synthes (USA) Products LLC is recalling six 3.5mm spinal screws that measure 4.0mm in diameter. The product was distributed to New Jersey.

    Product
    Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0238-2019·2018-10-31

    Synthes 3.0mm Headless Compression Screws Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 20 units of 3.0mm Headless Compression Screws because the product inside the package does not match the label.

    Product
    3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2247-2018·2018-06-27

    Synthes Graphic Case F/7.3mm Cannulated Screw Set Recalled for Measurement Error

    Synthes (USA) Products LLC is recalling three units of the Graphic Case F/7.3mm Cannulated Screw Set because the included gauges measure screws 5.41mm shorter than their actual length.

    Product
    Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2245-2018·2018-06-27

    Synthes Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set Recalled

    Synthes (USA) Products LLC is recalling 7 units of a combined cannulated screw set because the included gauges measure screws 5.41mm shorter than actual length.

    Product
    Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2246-2018·2018-06-27

    Synthes Graphic Case F/6.5mm Cannulated Screw Set Recalled for Measurement Error

    Synthes (USA) Products LLC is recalling four units of the Graphic Case F/6.5mm Cannulated Screw Set because the screw gauges measure 5.41mm shorter than the actual screw length.

    Product
    Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1916-2018·2018-05-30

    Synthes Torque Limiting Handle Recalled Due to Premature Rusting

    Synthes (USA) Products LLC is recalling 50 Torque Limiting Handles because high-carbon ball bearings may rust prematurely, causing functional degradation.

    Product
    Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1758-2018·2018-05-16

    Synthes Sciatic Nerve Retractor Recalled for Potential Microspore Formation

    Synthes (USA) Products LLC is recalling 235 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.

    Product
    Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1759-2018·2018-05-16

    Synthes Sciatic Nerve Retractor Recalled for Potential Microspore Formation

    Synthes (USA) Products LLC is recalling 196 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.

    Product
    Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 960 sterile 3.0 mm Reaming Rods because package seal defects may compromise sterility.

    Product
    3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2018·2018-03-14

    Synthes 2.5 mm Guide Rods Recalled for Potential Sterility Loss

    Synthes (USA) Products LLC is recalling 21 sterile 2.5 mm Guide Rods due to potential package seal defects that may compromise sterility.

    Product
    2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 2.5 mm Reaming Rods because package seal defects may have compromised sterility. The devices are used in orthopedic surgery.

    Product
    2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2018·2018-03-14

    Synthes Recalls Sterile Light Clip for Oracle Retractor Due to Potential Lack of Sterility

    Synthes (USA) Products LLC is recalling sterile Light Clips for the Oracle Retractor because potential gaps in the package seal may compromise sterility. The product is used during orthopedic surgery.

    Product
    Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2018·2018-03-14

    Synthes Recalls 2.5 mm Titanium Calibrated Reaming Rods Due to Sterility Concerns

    Synthes (USA) Products LLC is recalling 63 units of 2.5 mm Titanium Calibrated Reaming Rods because potential gaps in the package seal may have compromised product sterility.

    Product
    2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 1,144 sterile 2.5 mm Reaming Rods due to potential gaps in the package seal that may compromise sterility.

    Product
    2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2018·2018-03-14

    Synthes Recalls 2.5 mm Reaming Rods Due to Potential Sterility Loss

    Synthes (USA) Products LLC is recalling 216 units of 2.5 mm Reaming Rods because package seal defects may have compromised sterility.

    Product
    2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0604-2018·2018-02-21

    Synthes Recalls Titanium Trochanteric Fixation Nails Due to Missing Components

    Synthes (USA) Products LLC is recalling 4 units of sterile titanium trochanteric fixation nails because the locking mechanism and protective cap were missing.

    Product
    11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1383-2017·2017-03-08

    Synthes Recalls Mislabelled PRODISC Orthopedic Spinal Surgery Struts

    Synthes (USA) Products LLC is recalling two PRODISC Orthopedic Manual Surgical Instrument struts used in spinal surgery because they are incorrectly etched and labeled with the wrong size.

    Product
    PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
    Category
    Medical Device
    Distribution
    2 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.