🔍 RecallPedia

Trinity Acetabular Shell Product Usage: Total Hip Replacement.

Class I - Dangerous
🏥 Medical Devices Recalled: January 29, 2016 Corin USA Limited Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Cluster Shell 044mm Taper Size 1, Lot Code: 320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298; Cluster Shell 050mm Taper Size 2, Lot Codes: 321954, 322753, 322980; Cluster Shell 050mm Taper Size 3, Lot Codes:
  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:
Corin USA Limited
Reason for Recall:
Potential for abrasion of the sterile barrier pouches of the new packaging system.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Trinity Acetabular Shell Product Usage: Total Hip Replacement.

Product Codes/Lot Numbers:

Cluster Shell 044mm Taper Size 1, Lot Code: 320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298; Cluster Shell 050mm Taper Size 2, Lot Codes: 321954, 322753, 322980; Cluster Shell 050mm Taper Size 3, Lot Codes:

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1527-2016

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