EBI Field Action:

Acknowledgment and Receipt Form

ZimVie is conducting a medical device component correction for the lead wires that accompany the Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System. We have received complaints describing damage to the lead wire sheath (black cable) component and causing exposure of the wires. This could potentially lead to no therapeutic treatment signal being delivered to the electrodes, thereby resulting in a delay in treatment. ZimVie has received 1,020 non-reportable customer complaints (0.86% complaint rate) to date describing the issue, however, we have not received any reports of adverse events to date associated with this condition.

As a recent user of this product, you should have received in the mail a letter outlining these details; please complete the information to the right as acknowledgment of this Medical Device Correction Notice.

If you have further questions or concerns after reviewing your notice, please call customer service at 1-800-526-2579 x 6000. Customer Service Representatives are available from 8:30 a.m. to 5:00 p.m. ET, 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.