NuOss recallZ-0823-2022 · Ace Surgical Supply Co., Inc. · initiated Feb 2, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ace Surgical Supply Co., Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0823-2022
- Status
- Open, Classified
- Initiated by the company
- Feb 2, 2022
- Recalling firm
- Ace Surgical Supply Co., Inc.
- Quantity
- 31 eaches
- Product code
- NPM
- FDA submissions
- K043034
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
Product description
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Code information (models, lots, serial numbers)
Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NuOss 5091003Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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