Smith & Nephew Inc. recalls ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Pr…

Recall date

August 12, 2024

Source

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

Recall number

Z-3096-2024

FDA classification

Class II

Brand / firm

Smith & Nephew Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Sw…

Why it was recalled

Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility

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

What was recalled

ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1