Z-0823-2022Class II

NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog...

Name: Z-0823-2022 NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog...
Creator: Ace Surgical Supply Co., Inc.
Published: 2022-02-02
License: https://open.fda.gov/license/

Ace Surgical Supply Co., Inc. / initiated 2022-02-02 / Open, Classified / root cause: packaging

FDA source

Ace Surgical Supply Co., Inc. began a recall of NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250 on 2022-02-02. FDA classified it as Class II and gives the reason as "NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0823-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-02
Posted: 2022-03-24
Recalling firm: Ace Surgical Supply Co., Inc.
Product: NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Product code: NPM Bone Grafting Material, Animal Source
Reason for recall: NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Ace Surgical issued Urgent Voluntary Recall letter dated 2/4/22 to US customers via certified mail and customers outside of US contacted via email. Letter states reason for recall, health risk and action to take: Please refer to the lot number on the outer box label. The lot in question is BMBU21A 1. If you confirm this lot number on ACE Surgical Supply product, DO NOT USE THE PRODUCT and segregate it to prevent future use. Please be advised that the recalled lot identified was from a specific batch produced in October 2021. If you have received this notification, our shipping records confirm that you received this specific batch that was affected. All products subject to this RECALL will need to be returned to ACE Surgical. Please complete the RESPONSE form and follow the instructions for submission. If you do have product to be returned, please return the response form to [email protected]. If you do have inventory to return, once the response form is received and confirmed, an ARS Label will be issued. If you have any further questions, please contact Doreen Price 508-588-3100, Extension 781 or doreen price@acesurgical .com.
Quantity in commerce: 31 eaches
Distribution: Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
Product codes and lots: Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0823-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0823-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-30	2022-03-24

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)