FDA-Device2024-07-31Class II
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
LINK BIO CORP
Hazard
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.
Sold states
US Nationwide distribution in the states of FL, GA, KS, OH, WI.
Affected count
8 units
Manufactured in
69 King St Ste 2, Dover, NJ, United States
Products
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2445-2024Don't want to check this manually?
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