🔍 RecallPedia

GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

Class I - Dangerous
🏥 Medical Devices Recalled: December 7, 2021 DePuy Orthopaedics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452 GTIN: 10603295004189
  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:
DePuy Orthopaedics, Inc.
Reason for Recall:
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

Product Codes/Lot Numbers:

Lot #: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452 GTIN: 10603295004189

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0490-2022

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