Z-0489-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 19, 2022
- Initiation Date
- December 7, 2021
- Termination Date
- May 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 451 units
Product Description
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
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
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.
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