K2M, Inc Recall 87075
Description: Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
K2M, Inc Recall 87075 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0931-2021 |
| Event ID | 87075 |
| Event Description | Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System |
| Product Type | Devices |
| Distribution | Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore |
| Quantity | 248 units/1 each |
| Recall Reason | The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length). |
| Device Classification | 20210203 |
| Device Code Info | Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582 |
| Center Classification Date | 20210127 |
| Recall Initiation Date | 20201214 |
| Recalling Firm | K2M, Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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