GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling the GLOBAL UNITE REV STEM SZ 8 (Part Number: 110008600) due to a manufacturing defect affecting the spigot bore diameter. The defect may prevent the proximal body from separating from the stem without causing surgical delay and/or bone damage. The recall affects 3 units from Lot #9887449 and has been distributed worldwide, including across the United States and in numerous countries including Canada, the United Kingdom, Australia, and others.
The source 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: 3 units Lot/code info: Lot #: 9887449 GTIN:10603295004059
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.