Z-2445-2024 Class II Ongoing
FDA device recall Z-2445-2024 was initiated by LINK BIO CORP on June 27, 2024 and is designated Class II. Reason for recall: 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 int… The recall status is ongoing. Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2024
- Initiation Date
- June 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of FL, GA, KS, OH, WI.
Code Information
Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.