Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: 6105-0028, Part Number 1105-0028
- 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:
- Arthrosurface, Inc.
- Reason for Recall:
- Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Product Codes/Lot Numbers:
Catalog Number: 6105-0028, Part Number 1105-0028
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1110-2015
Related Recalls
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.