Recall Z-0078-2019— Incisive Surgical Inc

Name: FDA recall Z-0078-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-29

Class II · Terminated

Class II FDA medical device recall by Incisive Surgical Inc, initiated 2018-08-29, terminated 2019-03-18. It names one FDA 510(k) clearance: K120373. Product: INSORB SUBCUTICULAR SKIN STAPLER, REF 2030. Reason: Possible compromise of the sterile barrier integrity.

Recalling firm: Incisive Surgical Inc
Classification: Class II
Status: Terminated
Initiated: 2018-08-29
Terminated: 2019-03-18
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K120373 — INSORB ABSORBALBE STAPLEIncisive Surgical, Inc.·cleared 2012-03-16

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

INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

Reason for recall

Possible compromise of the sterile barrier integrity

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