Recall Z-0690-2017— Domain Surgical, Inc.

Name: FDA recall Z-0690-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-24

Class II · Terminated

Class II FDA medical device recall by Domain Surgical, Inc., initiated 2016-10-24, terminated 2017-04-11. It names one FDA 510(k) clearance: K141484. Product: FMsealer Open Shears. Model FM3001. Reason: Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage..

Recalling firm: Domain Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-24
Terminated: 2017-04-11
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K141484 — OPEN FMSEALERDomain Surgical, Inc.·cleared 2014-07-30

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

FMsealer Open Shears. Model FM3001

Reason for recall

Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.

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