Smith & Nephew, Inc. Recall 87717
Description: CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
Smith & Nephew, Inc. Recall 87717 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1510-2021 |
| Event ID | 87717 |
| Event Description | CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan. |
| Quantity | 2 units US and 193 units OUS. 195 units WW |
| Recall Reason | Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw |
| Device Classification | 20210505 |
| Device Code Info | Lot Number: 50906647 |
| Center Classification Date | 20210429 |
| Recall Initiation Date | 20210408 |
| Recalling Firm | Smith & Nephew, Inc. |
| Initial Notification | Letter |
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