Z-2445-2024 Class II Ongoing

Recalled by LINK BIO CORP — Dover, NJ

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.