Recall Z-1841-2019— Ethicon, Inc.

Name: FDA recall Z-1841-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-19

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2019-04-19, terminated 2021-02-05. It names one FDA 510(k) clearance: K946173. Product: ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. Reason: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot.

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-04-19
Terminated: 2021-02-05
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

ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

Reason for recall

Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

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