FDA-Device2025-10-08Class II
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Hazard
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Sold states
US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.
Affected count
3 units
Manufactured in
Am Aesculap-Platz 1, N/A, Tuttlingen, N/A, Germany
Products
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0027-2026Want us to check the next one for you?
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