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U.S. Department of Health and Human Services

Class 2 Device Recall BULKAMID, URETHRAL BULKING SYSTEM

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  Class 2 Device Recall BULKAMID, URETHRAL BULKING SYSTEM see related information
Date Initiated by Firm June 03, 2021
Create Date July 15, 2021
Recall Status1 Terminated 3 on April 20, 2022
Recall Number Z-2077-2021
Recall Event ID 88141
PMA Number P170023 
Product Classification Agent, bulking, injectable for gastro-urology use - Product Code LNM
Product BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Code Information Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA
Recalling Firm/
Manufacturer		 Axonics Modulation Technologies, Inc.
26 Technology Dr
Irvine CA 92618-2380
For Additional Information Contact Salvadore Palomares, RAC
949-396-6320
Manufacturer Reason
for Recall		 Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
FDA Determined
Cause 2		 Material/Component Contamination
Action On June 3, 2021 Axonics issued "Medical Device Recall" to all consignees via FedEx. In addition to informing consignees about the recalled product, the firm asked customers to take following actions: 1. Immediately review your inventory for the Lot No. specified in this notification and share this notice and Customer Response Form with appropriate staff. 2. If you further distributed this product, please notify those entities of this product recall. Please include a copy of this recall notification in your communication. 3. Quarantine and then discard any units of the impacted lots. Axonics will provide replacement product at no cost. 4. Complete and return the Customer Response Form within 10 working days to recall@axonics.com so that we are assured you have received this important communication. 5. Report any adverse health consequences with the use of this product to Axonics or to the FDAs MedWatch Adverse Event Reporting program 6.If there are any questions, please email to recall@axonics.com or call Axonics Customer Service at 1-877-929-6642 Action Taken by Axonics: 1. An alternate contract sterilization facility has already been qualified and is now being employed. 2. If you have any product from any of these lots, Axonics will replace the product at no cost. 3. Axonics will prioritize the replacement of product to customers affected by the recall and we respectfully request that you complete the Customer Response Form
Quantity in Commerce 2,702 units
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LNM and Original Applicant = Axonics Modulation Technologies, Inc.
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