DePuy Orthopaedics, Inc. Recall 89240
Description: GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
DePuy Orthopaedics, Inc. Recall 89240 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0487-2022 |
| Event ID | 89240 |
| Event Description | GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 |
| 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 | 3 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 #: 9809673 GTIN: 10603295004097 |
| 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 |
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