Smith & Nephew, Inc. recalls smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510

Recall date

February 19, 2019

Source

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

Recall number

Z-1028-2019

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain

Why it was recalled

Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

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

What was recalled

smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510