🔍 RecallPedia

SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

Class I - Dangerous
🏥 Medical Devices Recalled: August 14, 2015 Limacorporate S.p.A Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 14AA234, 14AA235, 14AA233
  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:
Limacorporate S.p.A
Reason for Recall:
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

Product Codes/Lot Numbers:

Lot Numbers: 14AA234, 14AA235, 14AA233

Distribution:

Distributed in: US, OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN, LA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2539-2015

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