FDA approvals and recalls

Bones and joints: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

New drug approvals

6 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.

At the source

  • Avtozma (tocilizumab)

    Approved for: AVTOZMA ® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) Adult patients with moderately to severel…

    BLA761498

  • Oziltus (denosumab-mobz)

    Approved for: Oziltus is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid t…

    BLA761457

  • Tyenne (tocilizumab-aazg)

    Approved for: TYENNE ® (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) • Adult patients with moderately to severe…

    BLA761275

  • Jubbonti (denosumab)

    Approved for: Jubbonti is a RANK ligand (RANKL) inhibitor indicated for treatment: • of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) • to increase bone mass in men…

    BLA761362

  • Idacio (adalimumab-aacf)

    Approved for: IDACIO is a tumor necrosis factor (TNF) blocker indicated for: • Rheumatoid Arthritis (RA) ( 1.1 ): reducing signs and symptoms, inducing major clinical response, inhibiting the p…

    BLA761255

  • Tofidence (tocilizumab)

    Approved for: TOFIDENCE™ (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) Adult patients with moderately to severe…

    BLA761354

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

Drug recalls

16 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

1,133 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Stimulator, Spinal-Cord, Implanted (Pain Relief)

    Reason: Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart,…

    Z-0311-2027

  • Implant, Cochlear

    Reason: Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits

    Z-0349-2027

  • Pulse Generator, Permanent, Implantable

    Reason: Software problem has the potential for an inaccurate displayed longevity estimate.

    Z-0302-2027

  • Pulse Generator, Permanent, Implantable

    Reason: Software problem has the potential for an inaccurate displayed longevity estimate.

    Z-0303-2027

  • Pulse Generator, Permanent, Implantable

    Reason: Software problem has the potential for an inaccurate displayed longevity estimate.

    Z-0304-2027

  • Screw, Fixation, Bone

    Reason: Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.

    Z-0157-2027

  • Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    Reason: Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for su…

    Z-0266-2027

  • Stimulator, Electrical, Implantable, For Incontinence

    Reason: Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for su…

    Z-0267-2027

  • Plate, Fixation, Bone

    Reason: Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant

    Z-0318-2027

  • Prosthesis, Toe, Hemi-, Phalangeal

    Reason: Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

    Z-0264-2027

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

386 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

230,594 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Arthralgia23,035 reports
  2. 2Rheumatoid arthritis21,647 reports
  3. 3Pain19,737 reports
  4. 4Joint swelling14,060 reports
  5. 5Fatigue13,899 reports
  6. 6Headache11,999 reports
  7. 7Nausea10,238 reports
  8. 8Pain in extremity8,660 reports
  9. 9Pneumonia8,508 reports
  10. 10Dizziness8,494 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on bones and joints

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Market reports on bones and joints

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