FDA recall Z-2445-2024

Product

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

US Nationwide distribution in the states of FL, GA, KS, OH, WI.

Key facts

Status

Ongoing

Initiation date

2024-06-27

Report date

2024-07-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dover, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2445-2024