FDAClass IIMay 29, 2019

Neomem Resorbable Collagen Membrane recall

Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen…

Why was Neomem Resorbable Collagen Membrane recalled?

Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255

Product
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen…
Recalling firm
Collagen Matrix, Inc.
Quantity
45 units -US;170 units OUS
Distribution
Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.
Recall date
May 29, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls