Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number 08-170-1010 - Lot Number 134926; Part Number 08-170-1011 - Lot Number 134927; Part Number 08-170-1006 - Lot Number 134929; Part Number 08-170-1008 - Lot Number 134931
- 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:
- Amendia, Inc
- Reason for Recall:
- Absent tantalum market pin.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.
Product Codes/Lot Numbers:
Part Number 08-170-1010 - Lot Number 134926; Part Number 08-170-1011 - Lot Number 134927; Part Number 08-170-1006 - Lot Number 134929; Part Number 08-170-1008 - Lot Number 134931
Distribution:
Distributed in: US, GA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0966-2017
Related Recalls
Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.