Recall Z-2486-2020— Ethicon, Inc.

Name: FDA recall Z-2486-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-10

Class II · Ongoing

Class II FDA medical device recall by Ethicon, Inc., initiated 2020-06-10. It names one FDA 510(k) clearance: K946173. Product: 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: Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years.

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-06-10
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K946173 — STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKETHICON, Inc.·cleared 1995-01-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.