Biomet recalls OrthoPak non-invasive bone growth stimulators made since May 2023 due to potential lead wire damage causing treatment delays. Affected units may not deliver therapeutic signals.
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 OrthoPak non-invasive bone growth stimulators made since May 2023. The recall is because damage to the black cable could prevent the device from delivering treatment signals, delaying healing.
The black lead wire sheath can get damaged, exposing the wires. This may cause the device to stop sending therapeutic signals to the electrodes, delaying bone healing treatment.
Patients using the OrthoPak system for bone nonunions after trauma are affected. Those with the device since May 2023 are most at risk.
Check for the part number 1067718 or UD-DI 00812301020232. Devices were distributed starting May 1, 2023.
Look for part number 1067718 or UD-DI 00812301020232 on the device label.
The black lead wire sheath can get damaged, potentially exposing wires and causing the device to stop delivering therapeutic signals, which may delay bone healing.
Check for the part number 1067710 or UD-DI 00812301020232. If you have the device since May 2023, contact Biomet for details.
The recall is for potential treatment delays, not immediate injury risks. The hazard does not involve physical harm like burns or fractures.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1617-2024 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1617-2024 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.
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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.
