20" Lead Wires, Replacement Part Number: 1067724-2
This recall is currently active, issued April 23, 2024. It was issued by Ebi, Llc.
- Company
- Ebi, Llc
- Recall Initiated
- March 22, 2024
- Posted
- April 23, 2024
- Recall Number
- Z-1618-2024
- Quantity
- 829 units (2 lead wires assembly)
- Firm Location
- Parsippany, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Distribution
US Nationwide distribution.
Lot / Code Info
UDI-DI: 00812301020300 All devices distributed since May 1, 2023
Root Cause
Device Design
Action Taken
ZimVie issued Urgent Medical Device Correction letter to Patients, Physicians, Sales Representatives on 3/22/24 . Letter states reason for recall, health risk and action to take: 1. Review this notification for awareness of the contents. 2. Before each use, inspect your device s lead wires (black cable) for damage. If found to be damaged, contact Customer Service at 1-800-526-2579 x 6000 for a complimentary replacement. 3. Complete the Acknowledgement and Receipt Form either by scanning the QR code on the postcard included with this letter and completing the online form or mailing back the completed postcard. To complete your Acknowledgement, you will need to include your Unique Patient Reference Number included on the top of the first page of this letter. This acknowledgement should be completed even if you do not have affected product. 4. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-526-2579 x 6000. Customer Service Representatives are available from 8:30 am to 5:00 pm (EST), Monday through Friday. At other times, please leave a clear message for a return call by the next business day. Alternatively, your questions may be emailed to ebi.csorders@zimvie.com.