[Recalled] Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper… | FDA 2021-06-02
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 | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301 |
|---|---|
| Brand / manufacturer | Biomet, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2260-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 02 June 2021 |
| EAN / barcode | 00880304468030 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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 Biomet, 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.