🔍 RecallPedia

GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

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 #: 9793653, 9802160, 9802161, 9802162, 9802163, 9802164, 9802165, 9802166, 9802167, 9802168, 9802169, 9802170, 9802171, 9802172, 9802173, 9802174, 9802175, 9802176, 9802177, 9802178, 9802179, 9802180, 9802181, 9802182, 9802183, 9802184, 9802185, 9802186, 9802187, 9802188, 9802189, 9802190, 9802191, 9818345, 9824373, 9824374, 9824375, 9824376, 9824377, 9824378, 9824379, 9824380, 9824381, 9824382, 9824383, 9824384, 9824385, 9824386, 9824387, 9824388, 9824389, 9824390, 9824391, 9824392, 9824393, 9824394, 9824395, 9824398, 9824399, 9824400, 9824401, 9824402, 9824403, 9832827, 9841211, 9841212, 9842708, 9842709, 9842710, 9842711, 9843084, 9851725, 9851727, 9851728, 9851729, 9851730, 9851731, 9851732, 9851733, 9851734, 9851736, 9851739, 9851742, 9851743, 9851744, 9864146, 9874719, 9874720, 9874721, 9874722, 9874724, 9874726, 9874727, 9874728, 9874729, 9874733, 9874739, 9874744 GTIN: 10603295004080
  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 10 Part Number: 110010100

Product Codes/Lot Numbers:

Lot #: 9793653, 9802160, 9802161, 9802162, 9802163, 9802164, 9802165, 9802166, 9802167, 9802168, 9802169, 9802170, 9802171, 9802172, 9802173, 9802174, 9802175, 9802176, 9802177, 9802178, 9802179, 9802180, 9802181, 9802182, 9802183, 9802184, 9802185, 9802186, 9802187, 9802188, 9802189, 9802190, 9802191, 9818345, 9824373, 9824374, 9824375, 9824376, 9824377, 9824378, 9824379, 9824380, 9824381, 9824382, 9824383, 9824384, 9824385, 9824386, 9824387, 9824388, 9824389, 9824390, 9824391, 9824392, 9824393, 9824394, 9824395, 9824398, 9824399, 9824400, 9824401, 9824402, 9824403, 9832827, 9841211, 9841212, 9842708, 9842709, 9842710, 9842711, 9843084, 9851725, 9851727, 9851728, 9851729, 9851730, 9851731, 9851732, 9851733, 9851734, 9851736, 9851739, 9851742, 9851743, 9851744, 9864146, 9874719, 9874720, 9874721, 9874722, 9874724, 9874726, 9874727, 9874728, 9874729, 9874733, 9874739, 9874744 GTIN: 10603295004080

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0486-2022

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