Howmedica Osteonics recalls specific Reliance LITe Nerve Hook Bayoneted models due to potential sharp edges causing injury during nerve retraction procedures.
Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was observed that some parts exhibited an edge on the intersection between the radius and the diameter of the probe.
Howmedica Osteonics is recalling certain Reliance LITe Nerve Hook Bayoneted models because they have sharp edges that could cause injury during medical procedures. This recall affects surgeons and medical staff using these tools.
The probe has a flat surface and sharp edges where the radius meets the diameter, which could cause injury during nerve retraction procedures. This design flaw may lead to cuts or tissue damage when used in spinal surgeries.
Surgeons and medical staff who use the Reliance LITe Nerve Hook Bayoneted models during spinal procedures are most at risk. The recall applies to specific lot numbers produced between 2018 and 2019.
Check for the model name 'Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip' and reference number 48066103. The affected units were produced in lots 183432, 183433, 183434, and 17E168.
Identify the model name and reference number to confirm if your device is affected.
The official recall does not state that the product is safe to use; it has been recalled due to potential sharp edges that could cause injury.
The recall record does not specify any remedy or action steps for affected products.
Lots 183432, 183433, 183434, and 17E168 are affected.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0657-2019 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0657-2019 from Howmedica Osteonics. 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.
