Nuvasive recalls PRECICE STRYDE devices for limb lengthening and fracture fixation due to reported pain and bony abnormalities at the telescoping nail segments interface. All affected models are listed in the recall notice.
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Nuvasive is recalling PRECICE STRYDE devices used for limb lengthening, fracture fixation, and bone transport. The recall is due to complaints of pain and bony abnormalities at the interface between telescoping nail segments. This could cause discomfort or complications in the affected area.
The hazard involves reported complaints of pain and bony abnormalities at the interface between telescoping nail segments. This occurs when the device segments move relative to each other, potentially causing discomfort or structural issues in the bone.
Patients using PRECICE STRYDE devices for limb lengthening, fracture fixation, or bone transport are likely affected. Those with the specific model numbers listed in the recall notice are at risk of experiencing pain or bony abnormalities at the interface between telescoping segments.
Check if your device has a model number starting with BT10, BT115, or BT10A/B/C/D/E/S/V/X with specific lengths and diameters listed in the recall notice. All affected models were sold with the same product codes.
Identify your PRECICE STRYDE device model by checking the product code on the device or packaging.
If your device is listed in the recall, contact Nuvasive directly for further instructions.
Check if your device model is listed in the recall notice (e.g., BT10-100C360-5, BT115-10A360-5). All affected models are included in the notice.
Contact Nuvasive directly to confirm if your device is affected and follow their instructions.
The recall is based on reports of pain and bony abnormalities at the interface between telescoping segments, which could cause discomfort or complications.
We’ve drafted a message you can send Nuvasive to request your refund or repair — edit it as you like.
Subject: Recall Z-1323-2021 — Nuvasive Nuvasive Hello, I own a Nuvasive that is covered by recall Z-1323-2021 from Nuvasive. 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.
