EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
- 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:
- Encore Medical, LP
- Reason for Recall:
- Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Product Codes/Lot Numbers:
UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0102-2024
Related Recalls
Knee and Humeral socket implants contain incorrect labeling.
Knee and Humeral socket implants contain incorrect labeling.
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Encore Medical
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.