[Recalled] AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium — After a three year term, there is a potential for the external packaging (steri… | FDA 2018-06-22
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium |
|---|---|
| Brand / manufacturer | Stryker Leibinger GmbH & Co. KG |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2915-2018 |
| Country of notice | Germany |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 June 2018 |
| EAN / barcode | 1000201577 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
This Class II recall concerns device products distributed in Germany 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 Stryker Leibinger GmbH & Co. KG
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.