Product Safety Recalls

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Axonics Modulation Technologies, Inc. Recall 88141

Description: BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

Axonics Modulation Technologies, Inc. Recall 88141 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2077-2021
Event ID88141
Event DescriptionBULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Product TypeDevices
DistributionUS nationwide distribution.
Quantity2,702 units
Recall ReasonLack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Device Classification20210721
Device Code InfoLot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA
Center Classification Date20210715
Recall Initiation Date20210603
Recalling FirmAxonics Modulation Technologies, Inc.
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