GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling the GLOBAL UNITE REV STEM SZ 10 (Product Code: 110010600) due to a manufacturing defect. Three units from Lot #9809673 may have an undersized spigot bore diameter, which could prevent proper separation of the proximal body from the stem. This defect could result in surgical delay and/or bone damage if revision surgery becomes necessary.
The affected stems 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 source does not specify a remedy or what actions 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: 3 units Lot/code info: Lot #: 9809673 GTIN: 10603295004097
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.