FDA-Device2024-09-18Class II
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
Smith & Nephew Inc.
Hazard
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Sold states
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, Switzerland, United Arab Emirates/Dubai (UAE).
Affected count
2961 units (OUS)
Manufactured in
150 Minuteman Rd, Andover, MA, United States
Products
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3097-2024Don't want to check this manually?
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