DePuy Orthopaedics, Inc. Recall 89240
Description: GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
DePuy Orthopaedics, Inc. Recall 89240 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0488-2022 |
| Event ID | 89240 |
| Event Description | GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 |
| Product Type | Devices |
| 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 | 870 units |
| Recall Reason | 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 |
| Device Classification | 20220119 |
| Device Code Info | Lot #: 9793650, 9793651, 9793652, 9802212, 9802213, 9802214, 9802215, 9802216, 9802217, 9802218, 9802219, 9802220, 9802221, 9802222, 9802223, 9802224, 9802225, 9802226, 9802227, 9802228, 9802229, 9802230, 9802231, 9802232, 9802233, 9802234, 9802235, 9802236, 9802237, 9802238, 9802239, 9802240, 9802241, 9802242, 9802243, 9802244, 9802245, 9802246, 9802249, 9802250, 9802251, 9802253, 9802254, 9802255, 9802256, 9802257, 9802258, 9802259, 9824440, 9824441, 9824442, 9824443, 9824445, 9824446, 9824447, 9824448, 9824449, 9824450, 9824451, 9824457, 9824458, 9824459, 9824461, 9824462, 9824463, 9824464, 9824465, 9824466, 9824467, 9824468, 9824469, 9824470, 9824471, 9824472, 9824473, 9824474, 9824475, 9851771, 9851772, 9851774, 9851775, 9851776, 9851777, 9851779, 9851780, 9851781, 9851784, 9851786, 9851787, 9851790, 9851791, 9851796, 9851799, 9851801, 9851802, 9851803, 9851804, 9851807, 9851809, 9874795, 9874796, 9874798, 9874799, 9874800, 9874801, 9874802, 9874803, 9874808, 9874809, 9874811, 9874826, 9874829, 9874831 GTIN: 10603295004127 |
| Center Classification Date | 20220111 |
| Recall Initiation Date | 20211207 |
| Recalling Firm | DePuy Orthopaedics, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |