AAP Implantate Ag recalls aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

Recall date

November 28, 2019

Source

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

Recall number

Z-1675-2020

FDA classification

Class II

Brand / firm

AAP Implantate Ag

Sold / distributed

Worldwide Distribution

Why it was recalled

The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.

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 Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00