AVID Medical, Inc. Recall 95515
Description: Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
AVID Medical, Inc. Recall 95515 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0390-2025 |
| Event ID | 95515 |
| Event Description | Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 117 eaches |
| Recall Reason | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions |
| Device Classification | 20241120 |
| Device Code Info | GTIN: 10809160421857 Lot Number: 1606092 |
| Center Classification Date | 20241114 |
| Recall Initiation Date | 20240920 |
| Recalling Firm | AVID Medical, Inc. |
| Initial Notification | |
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