Z-1096-2016Class II

NuOSS Cancellous Intended for use in dental surgery

Name: Z-1096-2016 NuOSS Cancellous Intended for use in dental surgery
Creator: Collagen Matrix Inc
Published: 2015-08-25
License: https://open.fda.gov/license/

Collagen Matrix, Inc / initiated 2015-08-25 / Terminated

FDA source

Collagen Matrix Inc began a recall of NuOSS Cancellous Intended for use in dental surgery on 2015-08-25. FDA classified it as Class II and gives the reason as "On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1096-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-25
Posted: 2016-03-11
Terminated: 2016-05-11
Recalling firm: Collagen Matrix, Inc
Product: NuOSS Cancellous Intended for use in dental surgery.
Product code: NPM Bone Grafting Material, Animal Source
Reason for recall: On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.
FDA root cause: Unknown/Undetermined by firm
Action: Collagen Matrix Inc. notified their sole customer on November 17, 2015. On August 25, 2015, during a review of inventory, tt was discovered that of the 171 units product shipped, 19 units may have been the incorrect size. For further questions please call (201) 405-1477
Quantity in commerce: 171 units
Distribution: US Distribution to the state of : MA
Product codes and lots: Reference No. BM2C20010-U Lot no. BM2CU15E2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1096-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1096-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-11

Product code NPM

K043034Class IIOsteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. / cleared 2005-08-04

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)