Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PNE Lead Implant Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall PNE Lead Implant Kitsee related information
Date Initiated by FirmJuly 15, 2024
Date PostedOctober 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0198-2027
Recall Event ID 99907
PMA NumberP190006 P180046 
Product Classification Stimulator, electrical, implantable, for incontinence - Product Code EZW
ProductPNE Lead Implant Kit REF: 1701
Code Information UDI: 10810005340134/ Lots: AK1Z531006 AK1Z531009 AK1Z531010 AK1Z531011 AK1Z531012 AK1Z531013 AK1Z531014 AK1Z531007 AK1Z531008 AK1Z531015 AK1Z531016 AK1Z531017 AK1Z531018 AK1Z531019 AK1Z631001 AK1Z631002 AK1Z631003 AK1Z631006 AK1Z631007 AK1Z631008 AK1Z631009 AK1Z731001 AK1Z731002 AK1Z631004 AK1Z631005 AK1Z731002 AK1Z731003 AK1Z731004 AK1Z731005 AK1Z731006 AK1Z731007 AK1Z731008 AK1Z731008 AK1Z731009 AK1Z731010 AK1Z731011 AK1Z731012 AK1Z731013 AK1Z731014 AK1Z731015 AK1Z731016 AK1A731017 AK1A731018 AK1A731019 AK1A731019 AK1A731020 AK1A731021 AK1A731022 AK1A731023 AK1A731024 AK1A731025 AK1A831001 AK1A831002 AK1A831004 AK1A831005 AK1A831006 AK1A831007 AK1A831008 AK1A831012 AK1A931006 AK1A931007 AK1A931008 AK1A931009 AK1A931010 AK1A931011 AK1A931012 AK1A931013 AK1A931014 AK1A931015 AK1AC31001 AK1AC31002 AK1AC31003 AK1AC31004 AK1AC31005 AK1A831003 AK1A831009 AK1A831010 AK1A831011 AK1A831012 AK1A831013 AK1A931015 AK1A931016 AK1A931017 AK1A931018 AK1A931019 AK1AA31001 AK1AA31002 AK1AA31003 AK1AA31004 AK1AA31005 AK1AA31006 AK1AA31007 AK1AA31008 AK1AA31009 AK1AA31010 AK1AA31011 AK1AA31012 AK1AA31013 AK1AA31014 AK1AA31015 AK1AA31016 AK1AA31017 AK1AA31018 AK1AA31019 AK1AA31020 AK1AA31021 AK1AB31001 AK1AB31002 AK1AB31003 AK1AB31004 AK1AB31005 AK1AB31006 AK1AB31007 AK1AB31008 AK1AB31009 AK1AB31010 AK1LB31001 AK1LB31002 AK1AB31011 AK1AB31012 AK1AB31013 AK1AB31014 AK1AB31015 AK1LB31003 AK1AC31001 AK1AC31005 AK1AC31006 AK1AC31007 AK1AC31008 AK1AC31009 AK1AC31010 AK1AC31011 AK1AC31012 AK1AC31013 AK1AC31014 AK1AC31015 AK1AC31016 AK1AC31017 AK1AC31018 AK1AC31019 AK1A141001 AK1A141002 AK1A141003 AK1A141004 AK1A141005 AK1A141006 AK1A141007 AK1A141009 AK1A141023 AK1A141024 AK1A141025 AK1A141026 AK1A141027 AK1A241000 AK1A241002 AK1A241003 AK1A241004 AK1A241005 AK1A241006 AK1A241008 AK1A831014 AK1A831015 AK1A831016 AK1A831017 AK1A831018 AK1A831019 AK1A831020 AK1A931001 AK1A931002 AK1A931003 AK1A931004 AK1A931005 AK1AA31001 AK1A141008 AK1A141010 AK1A141011 AK1A141012 AK1A141013 AK1A141014 AK1A141015 AK1A141016 AK1A141017 AK1A141018 AK1A141019 AK1A141020 AK1A141021 AK1A141022 AK1A141023 AK1A341001 AK1A341002 AK1A341003 AK1A341004 AK1A341005 AK1A241006 AK1A241007 AK1A241008 AK1A241009 AK1A241010 AK1A241011 AK1A241012 AK1A241013 AK1A241014 AK1A241015 AK1A241016 AK1A241017 AK1A241018 AK1A241019 AK1A241020 AK1A241021 AK1A241022 AK1A241023 AK1A241024 AK1A241025 AK1A241026 AK1A341005 AK1A341006 AK1A341007 AK1A341008 AK1A341009 AK1C341021 AK1C341022 AK1C441003 AK1C441004 AK1C441005 AK1C441006 AK1C441007 AK1C441009 AK1D441010 AK1Z531001 AK1Z531002 AK1Z531003 AK1Z531004 AK1Z531005 AK1Z531006
FEI Number 3002968685
Recalling Firm/
Manufacturer		 Axonics, Inc.
26 Technology Dr
Irvine CA 92618-2380
For Additional Information ContactClara Johnson
763-494-1133
Manufacturer Reason
for Recall		Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
FDA Determined
Cause 2		Component change control
ActionOn August 7, 2024, Axonics, issues a Urgent Medical Device Notification to affected consignees via UPS. Axonics asked consignees to take the following actions: 1. Immediately review your inventory for the Lot Numbers specified in this notification and share this notice and Recall Response Form with the 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 and Medline Industries notification in your communication. 3. Discard any syringes of the impacted lots. 4. Complete and return the Recall 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 the syringes to Axonics or to the FDA s MedWatch Adverse Event Reporting program. 6. Axonics respectfully requests that you complete and return the Recall Response Form
Quantity in Commerce18,294 kits
DistributionUS Nationwide distribution including in the states of FL, AL, NE, CA, NY,MI, SC, IL, NC, KY, VA, CO, KS, AZ, OH, MN, PA, ND, MD, OK, GA, AR, WI, TX, SD, CT, IN, LA, WA, OR, WV, MA, TN, MT, NJ, DE, ME, NM, IA, NH, MO, NV, MS, DC, ID, VT, WY, UT and the countries of United Kingdom & Australia.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = EZW
-
-