Z-1097-2016Class II

NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002...

Name: Z-1097-2016 NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002...
Creator: Collagen Matrix Inc
Published: 2013-05-13
License: https://open.fda.gov/license/

Collagen Matrix, Inc / initiated 2013-05-13 / Terminated / root cause: manufacturing process

FDA source

Collagen Matrix Inc began a recall of NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height)... on 2013-05-13. FDA classified it as Class II and gives the reason as "During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the...". 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-1097-2016
Classification: Class II
Status: Terminated
Initiated: 2013-05-13
Posted: 2016-03-11
Terminated: 2017-06-21
Recalling firm: Collagen Matrix, Inc
Product: NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
Product code: NPM Bone Grafting Material, Animal Source
Reason for recall: During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Collagen Matrix Inc., sent an email dated May 14, 2013 to its sole customer. The email described the product, problem and actions to be taken. The customer was instructed to return all product with expiration dates 12/2014 or earlier under Returned Goods, the firm will replace these products with new inventory; and return to Collagen Matrix, Inc., 15 Thornton Road, Oakland, NJ 07436 or quarantine products with expiration date 1/2016 until further notice. If you have any questions,call 201-405-1477 x 304 or email: www.collagenmatrix.com.
Quantity in commerce: 347 units
Distribution: US Distribution to state of: MA.
Product codes and lots: Lot BMCXU11P1. BMCXU11H3 Lot BMCXU11P1, BMCXU12P1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1097-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1097-2016	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)