[Recalled] Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications
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
| Product | Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications. |
|---|---|
| Brand / manufacturer | Zimmer Biomet, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1962-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 June 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The products do not have sufficient data to support the labeled shelf life of 10 years.
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.