Arthrex, Inc. Recall 87584
Description: Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Arthrex, Inc. Recall 87584 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1380-2021 |
| Event ID | 87584 |
| Event Description | Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico. |
| Quantity | 32 units |
| Recall Reason | It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. |
| Device Classification | 20210421 |
| Device Code Info | Part number: AR-13200T-15.0; Lot code:12135408 |
| Center Classification Date | 20210409 |
| Recall Initiation Date | 20210311 |
| Recalling Firm | Arthrex, Inc. |
| Initial Notification | |
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