FDA Device recall Z-0489-2022
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
- FDA Device
- Class II
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class II recall of GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100 by Depuy Orthopaedics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0489-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-07 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
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
Identifiers
| code_info | Lot#: 9792322, 9792323, 9793656, 9793942, 9793943, 9802283, 9802284, 9802285, 9802286, 9802287, 9802288, 9802289, 98022…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2022%22
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