Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718

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

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 [email protected].