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FDA Recalls

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices

FDA Market Approval

FDA Letter to Health Care Providers

Posted by the FDA on April 25, 2018.

The Issue: FDA is providing preliminary information concerning magnetic resonance (MR) thermometry reliability with magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) devices.

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FDA Class I Recall: Zimmer Biomet Comprehensive Reverse Shoulder Implant

Zimmer Biomet Comprehensive Shoulder Replacement

February 15, 2017, the FDA announced a Class I recall of the Zimmer Biomet Comprehensive Reverse Shoulder implant because these devices are fracturing at a higher rate than stated in the labeling. If this occurs, patients may need a revision surgery to remove or replace the device.

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FDA 101: Product Recalls

FDA 101 Product Recalls

Unfortunately, in recent years, drug and product recalls have become more common. Why? What happens and how does the process work? Who is responsible for making sure these products are adequately tested before hitting the market?

Questions? Our knowledgeable staff is available at (877) 284-6600.

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Hazard Alert: Stryker Hip Implant LFIT V40 Metal Heads – Taper Lock Failure

Accolade TMZF femoral System

On September 27, 2016, the Therapeutic Goods Administration (TGA) in Australia, in consultation with Stryker Orthopaedics, issued a hazard alert for a specific range of LFIT Anatomic CoCr V40 femoral heads.

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FDA Requires Pre-Market Approval for Metal-on-Metal Hip Implants

Hip problems

Today, the FDA issued a final order requiring manufacturers to submit a pre-market approval (PMA) application for two types of metal-on-metal hip replacement devices. These include ones with a:

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FDA Recall: MicroPort Orthopedics PROFEMUR Modular Neck Hip Implant

hip replacement

The FDA announced a Class I Recall — the most serious type of recall — on yet another hip implant device. According to the FDA alert, MicroPort Orthopedics received “reports of an unexpected rate of fractures after surgery related to” its PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254.

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FDA Recall Issued: Zimmer M/L Taper Hip Prosthesis

Hip problems

On June 8, 2015, the U.S. Food and Drug Administration (FDA) issued a Class I recall of the Zimmer M/L Taper with Kinective Technology Femoral Stems and Necks. The devices involved were manufactured and distributed from March 31, 2015 through April 20, 2015.

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