[Recalled] ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement. — Elevated levels of bacterial endotoxin and residual debris remain on the device… | FDA 2019-08-21

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.