Zimmer, Inc. recalls ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.

Recall date

June 17, 2015

Source

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

Recall number

Z-2060-2015

FDA classification

Class II

Brand / firm

Zimmer, Inc.

Sold / distributed

Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.

Why it was recalled

A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.

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

What was recalled

ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.