Synthes, Inc. recalls TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

Recall date

April 9, 2015

Source

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

Recall number

Z-1600-2015

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

Distribution US Nationwide and Switzerland.

Why it was recalled

TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.

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

What was recalled

TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.