Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 04026575034727 X-Small, Right; 04026575034741 Small, Right; 04026575034758 Small, Left; 04026575164042 Medium, Right; 04026575164059 Medium, Left; 04026575164028 Large, Right; Serial/Lot Numbers: 200818/1709 200818/1720 201013/0291 200513/2160 200818/1732 200623/4154 200812/1511 210302/2440
- 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:
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for Recall:
- There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Product Codes/Lot Numbers:
UDI-DI 04026575034727 X-Small, Right; 04026575034741 Small, Right; 04026575034758 Small, Left; 04026575164042 Medium, Right; 04026575164059 Medium, Left; 04026575164028 Large, Right; Serial/Lot Numbers: 200818/1709 200818/1720 201013/0291 200513/2160 200818/1732 200623/4154 200812/1511 210302/2440
Distribution:
Distributed in: AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1378-2022
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