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Recall Observatory FDA recall evidence

Device product

GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

Z-0489-2022

December 07, 2021

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 89240
Status
Terminated
Classification
Class II
Quantity
451 units
Official record key
device-enforcement:Z-0489-2022

Official wording

Reason: 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

Code information: Lot#: 9792322, 9792323, 9793656, 9793942, 9793943, 9802283, 9802284, 9802285, 9802286, 9802287, 9802288, 9802289, 9802290, 9802291, 9802292, 9802293, 9802294, 9802295, 9802296, 9802297, 9802298, 9802299, 9802300, 9802301, 9802302, 9802306, 9802307, 9802308, 9802309, 9824482, 9824484, 9824485, 9824486, 9824487, 9824488, 9824489, 9824490, 9824491, 9824492, 9824493, 9824494, 9824495, 9824496, 9832814, 9832815, 9832816, 9832828, 9841207, 9851826, 9851828, 9851830, 9851831, 9851833, 9851834, 9851835, 9851839, 9851840, 9885297, 9897488, 9897491 GTIN: 10603295004158

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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