DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot number 078T1141
- 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:
- A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Product Codes/Lot Numbers:
Lot number 078T1141
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1257-2022
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Class I - Dangerous
Their is a potential that the reamer may kick or bind up during or immediately prior to use.