[Recalled] Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine —
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine |
|---|---|
| Brand / manufacturer | BioPro, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2257-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 25 June 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Manufacturing flaw in the sterile barrier system
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 →
Related recalls from BioPro, Inc.
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.