🔍 RecallPedia

SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

Class I - Dangerous
🏥 Medical Devices Recalled: April 8, 2016 Limacorporate S.p.A Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600
  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:
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

Product Codes/Lot Numbers:

Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1711-2016

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