Medical device recalls Moderate risk

Bone Dowell Harvest Tubes recalled over labeling errors

Recall date
April 12, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Zimmer Biomet, Inc. recalls Bone Dowell Harvest Tubes
Recall number
Z-2059-2017
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND

Why it was recalled

mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.

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

What was recalled

Bone Dowell Harvest Tubes

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