NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099
Summary
The FDA issued a Class II for NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxil by Ace Surgical Supply Co., Inc.. Reason: NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal b.
Details
Source
Device Recall
External ID
Z-0823-2022
Action Date
2022-03-30
Status
Ongoing
Category
device
Product Description
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Lot/Code Info: Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
Quantity Affected: 31 eaches
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
Distribution
Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-02
Company
Brockton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ace Surgical Supply Co., Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ace Surgical Supply Co., Inc. have FDA actions?
This is the only FDA action we have on record for Ace Surgical Supply Co., Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0823-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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