GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling 140 units of GLOBAL UNITE STD STEM SZ 16 (Product Code: 110016100) distributed worldwide, including throughout the United States and multiple countries across Europe, Asia, Africa, and Oceania. The recalled 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 lots are identified by specific lot numbers ranging from 9793946 to 9887452, with GTIN 10603295004189.
The recall record does not specify a remedy or recommended 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: 140 units Lot/code info: Lot #: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452 GTIN: 10603295004189
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.