GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling the GLOBAL UNITE STD STEM SZ 8 (Part Number 110008100) due to a manufacturing defect. Certain units from this product line may have an undersized spigot bore diameter, which could prevent proper separation of the proximal body from the stem during revision surgery. This defect could result in surgical delay and/or damage to bone during the separation procedure. A total of 432 affected units were distributed worldwide, including throughout the United States and in Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, and the United Kingdom.
The recall affects 56 specific lot numbers (ranging from lot #9793035 through lot #9887446). Consumers or healthcare providers who have received units from these affected lots and bearing GTIN 10603295004042 should verify their product against the lot numbers listed in this recall. However, the source document does not specify a remedy or required action 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: 432 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.