FDA-Device2020-01-01Class III

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

AAP Implantate Ag
Hazard

Products were distributed with the incorrect instructions for use.

Sold states
Texas
Affected count
7 units
Manufactured in
Lorenzweg 5, Berlin, Germany
Products
INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0732-2020

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief