FDAClass IIIJanuary 23, 2019

Porcine Anorganic Bone Mineral 4.0cc recall: Labeling Error

Porcine Anorganic Bone Mineral 4.0cc

Why was Porcine Anorganic Bone Mineral 4.0cc recalled?

There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.

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?

UDI - (01)00813954022369(17)210430(10)PMCU18C4 Lot Number - PMCU18C4 Expiration Date - 04/30/2021

Product
Porcine Anorganic Bone Mineral 4.0cc
Recalling firm
Collagen Matrix Inc
Quantity
136 units
Distribution
FL, TX
Recall date
January 23, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
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