Nuvasive recalls PRECICE plates for limb lengthening and fracture fixation due to reported pain and bony abnormalities at the interface between telescoping nail segments.
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 plates used for limb lengthening and fracture repair because users reported pain and bony abnormalities at the connection points between the telescoping segments. This could cause discomfort or complications in the healing process.
The recall is based on complaints of pain and bony abnormalities at the interface where the telescoping segments of the plate connect. This could lead to discomfort or complications during the healing process but does not indicate a risk of serious injury.
Patients who have received PRECICE plates for limb lengthening, fracture fixation, or other orthopedic procedures are affected. Those with the specific plate models listed in the recall are most at risk.
Check if your PRECICE plate has a model code starting with LP4.5, DRF4.5, MLT4.5, MRT4.5, PLF4.5, PLT4.5, or PRF4.5 followed by a specific size and hole configuration. All affected models were sold with the same lot numbers.
Review the model code on your PRECICE plate to see if it matches the listed codes (e.g., LP4.5-DLF30, DRF4.5-DRF30).
Nuvasive is recalling these plates due to complaints of pain and bony abnormalities at the interface between the telescoping segments.
The recall does not require immediate discontinuation; however, you should check if your plate is affected and contact Nuvasive if you have concerns.
The official recall does not specify a remedy, so you should contact Nuvasive directly for guidance on next steps.
We’ve drafted a message you can send Nuvasive to request your refund or repair — edit it as you like.
Subject: Recall Z-1325-2021 — Nuvasive Nuvasive Hello, I own a Nuvasive that is covered by recall Z-1325-2021 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.
