Recall Z-2603-2016— Novus Scientific Ab

Name: FDA recall Z-2603-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-19

Class II · Terminated

Class II FDA medical device recall by Novus Scientific Ab, initiated 2016-07-19, terminated 2016-12-23. It names one FDA 510(k) clearance: K092224. Product: TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030. Reason: Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs..

Recalling firm: Novus Scientific Ab
Classification: Class II
Status: Terminated
Initiated: 2016-07-19
Terminated: 2016-12-23
Firm location: Uppsala, Sweden

510(k) clearances named in this recall

1 on FDA's record

K092224 — TIGR SURGICAL MESH , MODEL WK-6Novus Scientific Pte, Ltd.·cleared 2010-01-25

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

TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030

Reason for recall

Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.

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