FDA-Device2024-09-18Class II
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
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
US: 6305 units; OUS : 160 units
Manufactured in
150 Minuteman Rd, Andover, MA, United States
Products
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3096-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief