[Recalled] Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use. — The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of… | FDA 2014-09-09
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use. |
|---|---|
| Brand / manufacturer | Zimmer, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2737-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 09 September 2014 |
| EAN / barcode | 62155015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.
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 Zimmer, 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.