BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am,
Summary
The FDA issued a Class II for BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulka by Axonics Modulation Technologies, Inc.. Reason: Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized.
Details
Source
Device Recall
External ID
Z-2077-2021
Action Date
2021-07-21
Status
Terminated
Category
device
Product Description
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Lot/Code Info: Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA
Quantity Affected: 2,702 units
Reason for Recall
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Distribution
US nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-03
Company
Irvine, CA
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 157 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 (Axonics Modulation Technologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Axonics Modulation Technologies, Inc. have FDA actions?
This is the only FDA action we have on record for Axonics Modulation Technologies, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2077-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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