PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE recalled over sterility concerns

Recall date

March 22, 2017

Source

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

Official notice title

Smith & Nephew, Inc. recalls PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STE…

Recall number

Z-2036-2017

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

Internationally to the country of : India

Why it was recalled

This lot of left plates were laser etched and packaged as right plates.

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

What was recalled

PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116