Nuvasive recalls Precice Bone Transport 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 Bone Transport devices used for limb lengthening and fracture fixation because users have reported pain and bony abnormalities at the interface between the telescoping nail segments. This could lead to complications in bone healing.
The hazard involves complaints of pain and bony abnormalities at the interface between the telescoping nail segments of the device. This could potentially cause issues with bone healing or structural integrity during the treatment process.
Patients using Precice Bone Transport devices for limb lengthening, open or closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones are affected. Those with the specific model numbers listed in the recall are most at risk.
Check if your device has a model number starting with BT10, BT115, or BT10 with a specific length (e.g., 10.0mm x 360mm) and the listed part numbers in the recall notice. The devices are used for limb lengthening and fracture fixation procedures.
Identify your Precice Bone Transport device model by checking the product code on the device or packaging.
If your device is listed in the recall, contact NuVasive Specialized Orthopedics, Inc. for further instructions.
The Precice Bone Transport device is intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
All models listed in the recall notice, including BT10 and BT115 series with specific dimensions and part numbers.
No, the recall does not require immediate discontinuation of use. However, if your device is listed, you should contact NuVasive for further instructions.
We’ve drafted a message you can send Nuvasive to request your refund or repair — edit it as you like.
Subject: Recall Z-1324-2021 — Nuvasive Nuvasive Hello, I own a Nuvasive that is covered by recall Z-1324-2021 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.
