Biomet recalls SpinalPak Non-invasive Spine Fusion Stimulator System (since May 2023) due to potential lead wire damage causing treatment delays. Affected users should contact for remedy.
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
Biomet is recalling its SpinalPak Non-invasive Spine Fusion Stimulator System because damage to the lead wire sheath could cause treatment delays. This affects patients using the device for spine fusion after trauma.
The lead wire sheath (black cable) can get damaged, exposing the wires. This may prevent the device from delivering the therapeutic signal to the electrodes, delaying spine fusion treatment.
Patients using the SpinalPak system for spine fusion treatment after trauma are most at risk. The recall applies to devices distributed since May 1, 2023.
Check for the product name 'Biomet SpinalPak Non-invasive Spine Fusion Stimulator System' with part number 1067716. Devices were distributed starting May 1, 2023.
Reach out to Biomet for instructions on how to get a remedy for the recalled device.
The device may have a risk of delayed treatment if the lead wire sheath is damaged, but it is not unsafe for normal use.
The recall applies to devices distributed since May 1, 2023.
Contact Biomet for instructions on how to get a remedy for the recalled device.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1616-2024 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1616-2024 from Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
