FDA Device recall Z-2445-2024
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
- FDA Device
- Class II
- ongoing
- Published 2024-07-31
On 2024-07-31 the FDA classified a Class II recall of LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 by Link Bio, citing the LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was ins….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2445-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-27 |
| Published | 2024-07-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Link Bio |
| Distribution | US |
Product
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Reason
The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
Identifiers
| code_info | Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2445-2024%22
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