RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer.

Class I - Dangerous
🏥 Medical Devices Recalled: November 25, 2020 Biomet Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots 259830 259860 259880 259890 259910 259920 260020 260140 260160
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer.

Product Codes/Lot Numbers:

Lots 259830 259860 259880 259890 259910 259920 260020 260140 260160

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0627-2021

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