NuVasive recalls Precice Intramedullary Limb Lengthening systems for age, weight, and device count restrictions. Updated instructions clarify patients must be 18+, weigh at least 50 lbs, and no more than two devices can be implanted.
The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.
NuVasive is recalling its Precice Intramedullary Limb Lengthening (IMLL) and Short Systems. The update clarifies that patients must be at least 18 years old, weigh 50 lbs or more, and no more than two devices can be implanted at a time. This is a safety update to ensure proper use.
The update addresses potential risks from improper use. If patients are younger than 18 or weigh less than 50 lbs, or if more than two devices are implanted, the system could lead to complications. The recall ensures these safety limits are followed.
Patients who have received the Precice IMLL or Short Systems implants must be at least 18 years old and weigh 50 lbs or more. The recall applies to all devices manufactured between April 2015 and February 2021.
Check your device model numbers and item numbers, which include specific end caps, screws, and other components listed in the recall. Devices were manufactured between April 2015 and February 2021.
Check the updated instructions for age, weight, and device count requirements.
Yes, review the updated instructions to ensure you meet the age (18+), weight (50 lbs+), and device count (no more than two) requirements.
You should not use this system. Contact NuVasive for guidance on alternative options.
Devices manufactured between April 2015 and February 2021 are affected. Check your model numbers and item numbers against the list provided in the recall.
We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.
Subject: Recall Z-0319-2022 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-0319-2022 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.
