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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

DePuy Orthopaedics, Inc.: 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

Agency Publication Date: January 11, 2022
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Affected Products

Product: GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610

Lot #: 9792595, 9793039, 9802121, 9813506. 9818509, 9830922, 9840359,9858603 GTIN: 10603295004011

Lot Numbers:
9792595
Product: GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100

Lot # s 9793035, 9802134, 9802135, 9802136, 9802137, 9802138, 9802139, 9802140, 9802141, 9802142, 9802143, 9802144, 9802145, 9802146, 9802147, 9802148, 9802149, 9802150, 9802151, 9814515, 9817165, 9817166, 9817167, 9817168, 9817633, 9818331, 9824332, 9824334, 9824335, 9824336, 9824337, 9824338, 9824339, 9824340, 9824341, 9824342, 9824343, 9824344, 9824345, 9824346, 9824347, 9832804, 9851705, 9851706, 9851707, 9851708, 9862057, 9864147, 9874672, 9874674, 9874675, 9874676, 9874678, 9874682, 9874683, 9874686, 9874688, 9887446 GTIN: 10603295004042

Product: GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600

Lot #: 9887449 GTIN:10603295004059

Lot Numbers:
9887449
Product: GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

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

Lot Numbers:
9793653
Product: GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600

Lot #: 9809673 GTIN: 10603295004097

Lot Numbers:
9809673
Product: GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

Lot #: 9793650, 9793651, 9793652, 9802212, 9802213, 9802214, 9802215, 9802216, 9802217, 9802218, 9802219, 9802220, 9802221, 9802222, 9802223, 9802224, 9802225, 9802226, 9802227, 9802228, 9802229, 9802230, 9802231, 9802232, 9802233, 9802234, 9802235, 9802236, 9802237, 9802238, 9802239, 9802240, 9802241, 9802242, 9802243, 9802244, 9802245, 9802246, 9802249, 9802250, 9802251, 9802253, 9802254, 9802255, 9802256, 9802257, 9802258, 9802259, 9824440, 9824441, 9824442, 9824443, 9824445, 9824446, 9824447, 9824448, 9824449, 9824450, 9824451, 9824457, 9824458, 9824459, 9824461, 9824462, 9824463, 9824464, 9824465, 9824466, 9824467, 9824468, 9824469, 9824470, 9824471, 9824472, 9824473, 9824474, 9824475, 9851771, 9851772, 9851774, 9851775, 9851776, 9851777, 9851779, 9851780, 9851781, 9851784, 9851786, 9851787, 9851790, 9851791, 9851796, 9851799, 9851801, 9851802, 9851803, 9851804, 9851807, 9851809, 9874795, 9874796, 9874798, 9874799, 9874800, 9874801, 9874802, 9874803, 9874808, 9874809, 9874811, 9874826, 9874829, 9874831 GTIN: 10603295004127

Lot Numbers:
9793650
Product: GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

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

Lot Numbers:
9792322
Product: GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

Lot #: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452 GTIN: 10603295004189

Lot Numbers:
9793946

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89240
Status: Resolved
Manufacturer: DePuy Orthopaedics, Inc.
Manufactured In: United States
Units Affected: 8 products (28 units; 432 units; 3 units; 781 units; 3 units; 870 units; 451 units; 140 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.