Z-0027-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- August 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Reason for Recall
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Distribution Pattern
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.
Code Information
Model Number: GB943R, UDI-DI Number: 04046963805784. Serial Numbers: 4519, 4528, 4533.