🔍 RecallPedia

The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm

Class I - Dangerous
🏥 Medical Devices Recalled: December 20, 2017 Integra LifeSciences Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    TRL092002506 Lot Numbers: 19419-1 15916-1 15457-1 201274-1 201893-1 2046177 TRL092002507 Lot Numbers: 19419-2 15916-2 15457-2 201274-2 201893-2 2046178 TRL092002508 Lot Numbers: 19419-3 15916-3 15457-3 201274-3 201893-3 2046179 TRL092002509 Lot Numbers: 19419-4 15916-4 15457-4 201274-4 201893-4 20461710 TRL092002510 Lot Numbers: 19419-5 15916-5 15457-5 201274-5 201893-5 20461711 TRL092002511 Lot Numbers: 19419-6 15916-6 15457-6 201274-6 201893-6 20461712 TRL092002512 Lot Numbers: 19419-7 15916-7 15457-7 201274-7 201893-7 20461713 TRL092002513 Lot Numbers: 19419-8 15916-8 15457-8 201274-8 201893-8 20461714 TRL092002514 Lot Numbers: 19419-9 15916-9 15457-9 201274-9 201893-9 20461715 TRL092002515 Lot Numbers: 19419-10 15916-10 15457-10 201274-10 201893-10 20461716 TRL092002516 Lot Numbers: 19419-11 15916-11 15457-11 201274-11 201893-11 20461717
  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:
Integra LifeSciences Corp.
Reason for Recall:
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm

Product Codes/Lot Numbers:

TRL092002506 Lot Numbers: 19419-1 15916-1 15457-1 201274-1 201893-1 2046177 TRL092002507 Lot Numbers: 19419-2 15916-2 15457-2 201274-2 201893-2 2046178 TRL092002508 Lot Numbers: 19419-3 15916-3 15457-3 201274-3 201893-3 2046179 TRL092002509 Lot Numbers: 19419-4 15916-4 15457-4 201274-4 201893-4 20461710 TRL092002510 Lot Numbers: 19419-5 15916-5 15457-5 201274-5 201893-5 20461711 TRL092002511 Lot Numbers: 19419-6 15916-6 15457-6 201274-6 201893-6 20461712 TRL092002512 Lot Numbers: 19419-7 15916-7 15457-7 201274-7 201893-7 20461713 TRL092002513 Lot Numbers: 19419-8 15916-8 15457-8 201274-8 201893-8 20461714 TRL092002514 Lot Numbers: 19419-9 15916-9 15457-9 201274-9 201893-9 20461715 TRL092002515 Lot Numbers: 19419-10 15916-10 15457-10 201274-10 201893-10 20461716 TRL092002516 Lot Numbers: 19419-11 15916-11 15457-11 201274-11 201893-11 20461717

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1463-2018

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