ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W 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
FDA Recall Z-1842-2019 · Posted None
Advertisement
Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeGAQ
Date Initiated2019-04-19
Date Terminated2021-02-05
Product Quantity36 eaches
Reason for Recall
Possibility that a suture raw material containing
high endotoxin levels was used in the manufacturing of this lot
Firm Action
Ethicon notified primary and secondary US consignees by telephone on 4/19/19 and follow-up letter dated April 24, 2019 stating reason for recall, health risk and action to take: examine inventory, remove product for return. Complete the Business Reply Form (BRF) to Stericycle at 1-844-721-3045 or [email protected].
Questions regarding this action or to report any customer complaints, please
contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement