Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot number PM00208
- 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:
- Miami Device Solutions, LLC.
- Reason for Recall:
- Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.
Product Codes/Lot Numbers:
Lot number PM00208
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0603-2020