Z-0752-2019Class III

Porcine Anorganic Bone Mineral 4.0cc

Name: Z-0752-2019 Porcine Anorganic Bone Mineral 4.0cc
Creator: Collagen Matrix Inc
Published: 2018-10-30
License: https://open.fda.gov/license/

Collagen Matrix, Inc / initiated 2018-10-30 / Terminated / root cause: manufacturing process

FDA source

Collagen Matrix Inc began a recall of Porcine Anorganic Bone Mineral 4.0cc on 2018-10-30. FDA classified it as Class III and gives the reason as "There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0752-2019
Classification: Class III
Status: Terminated
Initiated: 2018-10-30
Posted: 2019-01-17
Terminated: 2020-05-12
Recalling firm: Collagen Matrix, Inc
Product: Porcine Anorganic Bone Mineral 4.0cc
Product code: NPM Bone Grafting Material, Animal Source
Reason for recall: There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On October 30, 2018 Collagen Matrix, notified their 2 distributors of the issue via email. The two distributors provided notices to their customers. Customers were advised to take the following actions: 1. If any of the items noted in the scope of the letter is held in stock, please return them along with a copy of the letter to the address provided. Replacement product will be provided upon receipt of the return. 2. Complete the Certificate of Acknowledgement within 15 days of receipt and email the completed form to the email address noted within your letter.
Quantity in commerce: 136 units
Distribution: FL, TX
Product codes and lots: UDI - (01)00813954022369(17)210430(10)PMCU18C4 Lot Number - PMCU18C4 Expiration Date - 04/30/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0752-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0752-2019	Class III	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-17

Product code NPM

K140714Class IIPorcine Anorganic Bone MineralCollagen Matrix, Inc. / cleared 2014-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)