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.

26–50 of 164

  • SevereFDA (Devices)·Z-0572-2021·2020-12-23

    DePuy Synthes 10.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.5mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0578-2021·2020-12-23

    DePuy Synthes 13.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 13.5mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0581-2021·2020-12-23

    DePuy Synthes 15.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 15.0mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue or bone damage.

    Product
    DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0585-2021·2020-12-23

    DePuy Synthes 17.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 17.0mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0574-2021·2020-12-23

    DePuy Synthes 11.5mm Reamer Head Recalled for Breakage Risk

    Synthes (USA) Products LLC is recalling DePuy Synthes 11.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0586-2021·2020-12-23

    DePuy Synthes 17.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 17.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0582-2021·2020-12-23

    DePuy Synthes 15.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 15.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0579-2021·2020-12-23

    DePuy Synthes 14.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 14.0MM Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0571-2021·2020-12-23

    DePuy Synthes 10.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.0MM Reamer Heads for RIA 2 because breakage exceeds expected rates, causing potential tissue or bone damage.

    Product
    DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0576-2021·2020-12-23

    DePuy Synthes 12.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 12.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0584-2021·2020-12-23

    DePuy Synthes 16.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 16.5mm reamer heads because breakage exceeds expected rates, causing tissue and bone damage.

    Product
    DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0575-2021·2020-12-23

    DePuy Synthes 12.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 12.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0573-2021·2020-12-23

    DePuy Synthes 11.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 11.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0577-2021·2020-12-23

    DePuy Synthes 13.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 13.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0583-2021·2020-12-23

    DePuy Synthes 16.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 16.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0587-2021·2020-12-23

    DePuy Synthes 18.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 18.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0406-2021·2020-11-11

    Synthes Recalls SYN MESH Cages Due to Incorrect Labeling

    Synthes (USA) Products LLC is recalling 9 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical device' instead of 'specially controlled medical device.'

    Product
    SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - 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-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
  • LowFDA (Devices)·Z-0410-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 23 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'

    Product
    END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - 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
  • LowFDA (Devices)·Z-0411-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 9 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'

    Product
    END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - 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-0407-2021·2020-11-11

    Synthes SYNMesh Vertebral Body Replacement Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 5 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as general medical devices.

    Product
    SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - 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 sui
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0408-2021·2020-11-11

    Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 16 SynMesh Cages distributed in Japan because the statutory label incorrectly identified them as general medical devices.

    Product
    END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - 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
  • LowFDA (Devices)·Z-0404-2021·2020-11-11

    Synthes SYNMesh Vertebral Body Replacement Devices Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 12 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'

    Product
    SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - 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-0416-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 6 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
    STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - 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 t
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0412-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System because the statutory label incorrectly stated 'general medical device' instead of 'specially controlled medical device'.

    Product
    END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - 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

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.