(877) 284-6600
Local (816) 221-6600

FDA Recalls

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.

Read More


FDA Basics You Should Know

FDA in magnifying glass

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

Read More


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.

Read More


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.

Read More


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:

Read More


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.

Read More


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.

Read More