OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
Class I - DangerousWhat Should You Do?
- Check if you have this product: LOT # 31706
- 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:
- OMNIlife science Inc.
- Reason for Recall:
- Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
Product Codes/Lot Numbers:
LOT # 31706
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2479-2019
Related Recalls
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery