ROSA Surgical Device 2.5.8
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial No. RO10011, RO10014, RO13023 and RO13027
- 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:
- Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ROSA Surgical Device 2.5.8
Product Codes/Lot Numbers:
Serial No. RO10011, RO10014, RO13023 and RO13027
Distribution:
Distributed in: AR, OH, MI, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0178-2018
Related Recalls
Device has the potential for fracture during use.
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Zimmer Biomet
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.