Recall Z-1703-2021— Zavation

Name: FDA recall Z-1703-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-25

Class II · Terminated

Class II FDA medical device recall by Zavation, initiated 2021-03-25, terminated 2023-03-20. It names one FDA 510(k) clearance: K141419. Product: ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.. Reason: Products distributed as sterile may not have been adequately sterilized.

Recalling firm: Zavation
Classification: Class II
Status: Terminated
Initiated: 2021-03-25
Terminated: 2023-03-20
Firm location: Flowood, MS, United States

510(k) clearances named in this recall

1 on FDA's record

K141419 — ZVPLASTYZavation, LLC·cleared 2014-09-12

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

ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.

Reason for recall

Products distributed as sterile may not have been adequately sterilized

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