Recall Z-1110-2017— Biom'up

Name: FDA recall Z-1110-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-02

Class II · Terminated

Class II FDA medical device recall by Biom'up, initiated 2016-12-02, terminated 2017-05-05. It names one FDA 510(k) clearance: K103087. Product: RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.. Reason: Lack of sterility assurance.

Recalling firm: Biom'up
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Terminated: 2017-05-05
Firm location: St Priest, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K103087 — COVAMAX RESORBABLE COLLAGEN MEMBRANEBiom'Up Sas·cleared 2011-08-26

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

RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.

Reason for recall

Lack of sterility assurance

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