Medical device recalls Moderate risk

ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1 recalled over labeling errors

Recall date
July 27, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Synvasive Technology Inc recalls ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures…
Recall number
Z-1676-2020
FDA classification
Class II
Brand / firm
Synvasive Technology Inc
Sold / distributed
US distribution to states of AL and NY

Why it was recalled

Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.

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

What was recalled

ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer

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