GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics is recalling 870 units of the GLOBAL UNITE STD STEM Size 12 hip replacement component worldwide, including distribution throughout the United States and multiple countries in Europe, Asia, Africa, and Oceania. The recalled stems may have an undersized spigot bore diameter, which could prevent the proximal body from separating from the stem during revision surgery without causing surgical delay and/or bone damage.
The recall affects specific lot numbers ranging from 9793650 through 9874831. The source record does not specify what action affected consumers should take.
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: 870 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.