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Terminated

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

FDA Recall Z-1110-2017 · Posted 2017-01-27

Recalling FirmBiom'up
Recall StatusTerminated
Product CodeNPL
Date Initiated2016-12-02
Date Terminated2017-05-05
Product Quantity1,682 units

Reason for Recall

Lack of sterility assurance

Firm Action

An Urgent Medical Device Recall letter was mailed to affected customer on 12/02/2016 to inform them of the recall. The reason and actions to be taken were explained in the letter. Customer was asked to examine their inventory and contact Biom'Up to arrange for return of product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed to a sole distributor in NC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103087COVAMAX RESORBABLE COLLAGEN MEMBRANEBiom'Up Sas · 2011-08-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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