Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers/UDI : 626440 (01)00880304474611(17)310409(10)626440 626450 (01)00880304474611(17)310322(10)626450 626460 (01)00880304474611(17)310402(10)626460 626890 (01)00880304474611(17)310323(10)626890 678370 (01)00880304474611(17)310419(10)678370 678770 (01)00880304474611(17)310419(10)678770 678800 (01)00880304474611(17)310409(10)678800 695830 (01)00880304474611(17)310412(10)695830
- 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:
- Biomet, Inc.
- Reason for Recall:
- Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Product Codes/Lot Numbers:
Lot Numbers/UDI : 626440 (01)00880304474611(17)310409(10)626440 626450 (01)00880304474611(17)310322(10)626450 626460 (01)00880304474611(17)310402(10)626460 626890 (01)00880304474611(17)310323(10)626890 678370 (01)00880304474611(17)310419(10)678370 678770 (01)00880304474611(17)310419(10)678770 678800 (01)00880304474611(17)310409(10)678800 695830 (01)00880304474611(17)310412(10)695830
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2259-2021
Related Recalls
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.