AAP Implantate Ag recalls aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the…

Recall date

January 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1019-2019

FDA classification

Class II

Brand / firm

AAP Implantate Ag

Sold / distributed

Worldwide Distribution - US Nationwide in the state of Texas and country of Germany

Why it was recalled

There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.

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

What was recalled

aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.