GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling GLOBAL UNITE STD STEM size 6 (part number 11000610) due to a manufacturing defect where the stems may have an undersized spigot bore diameter. This defect could prevent the proximal body from separating from the stem without causing surgical delay and/or bone damage. The recall affects 28 units distributed worldwide, including throughout the United States and multiple other countries including Canada, the United Kingdom, Australia, and others.
The affected units are identified by lot numbers 9792595, 9793039, 9802121, 9813506, 9818509, 9830922, 9840359, and 9858603 (GTIN: 10603295004011). The source document does not specify a remedy or corrective action for 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: 28 units Lot/code info: Lot #: 9792595, 9793039, 9802121, 9813506. 9818509, 9830922, 9840359,9858603 GTIN: 10603295004011
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.