The Recall Desk
HighFDA (Devices)·Z-1110-2017·Announced 2017-02-08

Biom'up Recalls Renovix Collagen Membranes Due to Sterility Assurance Concerns

Biom'up is recalling 1,682 units of Renovix Guided Healing Collagen Membranes due to a lack of sterility assurance. The products were distributed to a sole distributor in North Carolina.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of sterility assurance in a medical device used in oral surgery, which presents a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biom'up is recalling 1,682 units of the Renovix Guided Healing Collagen Membrane. The product is intended for use in oral surgical procedures. The recall is being conducted due to a lack of sterility assurance.

The affected products are identified by specific lot numbers, including MCG16003.133034 through MCG16003.133254. The recall number is Z-1110-2017.

The products were distributed to a sole distributor in North Carolina. Consumers and healthcare providers should stop using the affected products and contact the recalling firm for further instructions.

The recalled product

Product
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
Manufacturer
Biom'up
Category
Medical Device — Oral Surgical
Hazard
Affected units
1,682

Distribution

Distributed in 1 state:

Related recalls

Same hazard · sterility assurance

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