Recall Z-2761-2016— Riverpoint Medical, LLC

Name: FDA recall Z-2761-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-05

Class II · Terminated

Class II FDA medical device recall by Riverpoint Medical, LLC, initiated 2016-08-05, terminated 2016-12-22. It names one FDA 510(k) clearance: K100006. Product: Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.. Reason: Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging..

Recalling firm: Riverpoint Medical, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-08-05
Terminated: 2016-12-22
Firm location: Portland, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K100006 — HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEEDRiverpoint Medical·cleared 2010-05-10

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

Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

Reason for recall

Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.

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