Medical device recalls

AAP Implantate Ag recalls INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425

Recall date
January 25, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0732-2020
FDA classification
Class III
Brand / firm
AAP Implantate Ag
Sold / distributed
Texas

Why it was recalled

Products were distributed with the incorrect instructions for use.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425

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