Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF: 1150000 Lot: 0207029284
- 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:
- Medtronic Xomed, Inc.
- Reason for Recall:
- One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Product Codes/Lot Numbers:
REF: 1150000 Lot: 0207029284
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2284-2013
Related Recalls
Due to out of the box wobble of the driver.
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
Product was distributed past expiration date.