FDA Medical Device Recalls (openFDA)
Ace Surgical Supply Co., Inc.: NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
- Recall number
- Z-0823-2022
- 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
- Status
- Open, Classified
- Initiated
- 2022-02-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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 doreenprice@acesurgical.com. 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
- 31 eaches
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
- Lot, serial or model codes
- Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
- 510(k) numbers
- ["K043034"]
- PMA numbers
- not on file
- Product code
- NPM
- Firm FEI
- 1287163
- Firm city
- Brockton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28