Medical device recalls Moderate risk

LINK BIO CORP recalls LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

Recall date
June 27, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2445-2024
FDA classification
Class II
Brand / firm
LINK BIO CORP
Sold / distributed
US Nationwide distribution in the states of FL, GA, KS, OH, WI.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

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