NuVasive Precice IMLL System: Update for Age/Weight Limits and Device Count
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61619-nuvasive-precice-imll-system-update-for-age-weight-limits-and.
Source Summary by GovInfoNow · govinfonow.com/recall/61619-nuvasive-precice-imll-system-update-for-age-weight-limits-and · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0319-2022
Cite this page
“NuVasive Precice IMLL System: Update for Age/Weight Limits and Device Count.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61619-nuvasive-precice-imll-system-update-for-age-weight-limits-and. Based on FDA recall #Z-0319-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0319-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
NuVasive- Category
Medical device
What to do — step by step
Review Product Instructions
Check the updated instructions for age, weight, and device count requirements.
Where it went and when
Where it was distributed
Distributed in 45 states and D.C. and Puerto Rico, and outside the U.S.
FDA distribution: “U.S.: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Argentina, Australia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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.
- Official source: FDA Recall #Z-0319-2022 (October 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0319-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.