GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling 451 units of the GLOBAL UNITE STD STEM SZ 14 hip implant stem (Product Code 110014100) worldwide, including throughout the United States and multiple countries across Europe, Asia, Africa, and Oceania. The recall was issued because these stems may have an undersized spigot bore diameter, which could prevent the proximal body from separating from the stem during revision surgery, potentially resulting in surgical delay and/or bone damage.
The affected stems are identified by specific lot numbers ranging from 9792322 through 9897491, with a GTIN of 10603295004158. According to the recall record, no remedy is specified for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: 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. Quantity: 451 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.