prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 00843193113856; Lot 2024-0482
- 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:
- Centinel Spine, Inc.
- Reason for Recall:
- During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Product Codes/Lot Numbers:
UDI-DI 00843193113856; Lot 2024-0482
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3212-2024
Related Recalls
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.