When Trusted Medical Devices Fail Patients

For years, patients have assumed that if a medical device reaches the market, it has been properly vetted, tested, and cleared for use. The reality is far more complicated.

The recent FDA Class I recall involving certain Stryker temporomandibular joint (“TMJ”) implants used to reconstruct or replace the jaw joint connecting the lower jaw to the skull, underscores a larger concern in medical device safety: even highly specialized implants can reach patients before critical design issues are fully discovered. According to the FDA, the recall involved a discrepancy between the screw-hole position listed in the design specifications and the actual fossa design, creating a risk that screws could penetrate the cranial vault and lead to dural tissue damage, bleeding, cerebrospinal fluid leak, meningitis, or other serious injury.

As someone who has spent years representing victims injured by defective medical and dental devices, I can tell you this is not an isolated event.

“What’s alarming is not simply that recalls happen,” said Scott E. Charnas, Esq., founder of Charnas Law Firm, P.C. “It’s the frequency with which we continue to see patients suffer life-altering injuries tied to products they were told were safe. In many of these cases, patients are only discovering the true source of their injuries years later.”

The numbers surrounding medical device recalls continue to raise serious questions across the healthcare and legal industries. According to FDA data, thousands of medical device recalls have been issued over the past decade, including Class I recalls reserved for situations involving a reasonable probability of serious injury or death. The medical device industry itself exceeds $500 billion globally, with manufacturers often operating under aggressive timelines to bring products to market.

For patients, the consequences are not abstract; they are physical, financial, and permanent.

Many individuals impacted by defective implants face:

• multiple revision surgeries

• chronic nerve pain

• infection risks

• bone loss and structural damage

• long-term disability

• substantial medical costs and lost income

“We continue seeing cases where patients trusted the system, trusted their doctors, and trusted the manufacturers behind these devices,” Charnas added. “When those systems fail, the impact follows people for the rest of their lives.”

The broader issue extends beyond a single manufacturer or product category. Litigation involving dental devices, orthopedic implants, surgical mesh, joint replacements, and other implanted products continues to grow nationwide as more patients come forward alleging inadequate warnings, flawed design, and insufficient long-term testing.

Regulatory clearance does not always equal long-term safety, and that distinction matters.

As scrutiny surrounding medical device oversight intensifies, accountability will continue becoming a central issue for manufacturers, regulators, and healthcare providers alike. Patients deserve transparency before products enter the market — not years after injuries have already occurred.