PlainRecalls
FDA Devices Moderate Class II Ongoing

PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870

Reported: July 8, 2020 Initiated: June 10, 2020 #Z-2486-2020

Product Description

PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870

Reason for Recall

Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years

Details

Recalling Firm
Ethicon, Inc.
Units Affected
99,612 eaches
Distribution
No domestic distribution. Foreign distribution to Algeria Angola Australia Austria Azerbaijan Bahrain Belgium Bosnia and Herzegovina Canada Chad Chile Czechia Egypt Finland France Gabon Germany Greece Hong Kong Iceland India Iran Ireland Israel Italy Japan Jordan Kenya Kuwait Latvia Lebanon Libya Lithuania Mauritius Morocco Mozambique Netherlands (the) New Caledonia New Zealand Nigeria Oman Philippines Poland Portugal Qatar Republic of North Macedonia Russian Federation (the) Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Thailand Tunisia Turkey United Arab Emirates (the) United Kingdom of Great Britain and Northern Ireland (the)
Location
Somerville, NJ

Frequently Asked Questions

What product was recalled?
PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870. Recalled by Ethicon, Inc.. Units affected: 99,612 eaches.
Why was this product recalled?
Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
Which agency issued this recall?
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2486-2020.