Zimmer Biomet Receives FDA Class I Recall for Shoulder Device

The Zimmer Biomet shoulder device is facing a class 1 recall from the FDA.

Due to a “higher fracture rate than stated” the Food and Drug Administration (FDA) has issued a class one recall of the Zimmer BiometZimmer biomet reverse shoulder device. Such recalls are reserved for products that “will cause serious adverse health consequences or death.”

This medical device recall, the most serious recall category, was issued this February. The recall reportedly included 3,662 devices.

Zimmer Biomet
Notice that risk managers received related to Zimmer Biomet recall.

The company acknwledged that these shoulder trays, all manufactured prior to September 2011, would fracture easily.

Risks included a need for revision surgery. According to experts, such surgeries might lead to permanent loss of shoulder function, infection and even death.”

Patients that may have received the Zimmer Biomet device may be entitled to compensation for their pain and/or suffering. For more information about filing a claim through Medical Claim Legal, complete a claim form at this link.

Pharmco Laboratories

SkinCare Co. Pharmco Laboratories Receives Warning From FDA

Pharmco Laboratories received a warning letter from the FDA citing 4 violations.

Pharmco Laboratories received a warning letter from the Food and Drug Administration. The letter to the Florida-based skincare manufacturer “summarized significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”

In the letter posted to the agencywebsite, four specific violation were referenced.

Pharmco Laboratories was accused of presenting an allergy risk to consumers. The FDA states that there has been insufficient evidence of the proper cleaning of equipment that came in contact with major allergens. Dietary supplements, for example, containing soybeans used the same dryer as the ingreditents in skincare items.

The FDA warning letter stated that “repeated lapses demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs.”