GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling 781 units of GLOBAL UNITE STD STEM SZ 10 hip implant stems worldwide due to a manufacturing defect. The stems may have an undersized spigot bore diameter, which could prevent proper separation of the proximal body from the stem during revision surgery, potentially causing surgical delays and bone damage. The affected product was distributed across the United States and 22 other countries, with multiple lot numbers identified from 9793653 through 9874744.
The recall affects hip implant stems that may already be implanted in patients. Consumers should contact DePuy Orthopaedics, Inc. or their healthcare provider with questions about whether their implant is affected. The recall record does not specify a remedy or instructions for affected consumers to follow.
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: 781 units Lot/code info: 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 record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.