ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial No. BR16004, BR15002, and BR15003
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer Biomet, Inc.
- Reason for Recall:
- Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
Product Codes/Lot Numbers:
Serial No. BR16004, BR15002, and BR15003
Distribution:
Distributed in: US, DC
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0105-2018
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