Recall record at a glance
| Official record | Z-0500-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | NuVasive Specialized Orthopedics, Inc. |
| Report date | Nov 27, 2024 |
| Recall initiation date | Sep 30, 2024 |
| Quantity | 164 devices |
| Location | Aliso Viejo, CA, United States |
Official product description
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 265mm PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 280mm PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 305mm PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 265mm PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 280mm PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 305mm PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm The Precice Max Nail is intended to stabilize fractures, nonunions, and malunions of the femur, tibia, and humerus. In addition, the Precice Nail is intended to provide magnetically controlled lengthening of long bones and/or transporting of bone segments in the femur, tibia, and humerus.
Why the product was recalled
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
Distribution information
U.S distribution to states of: FL and NV.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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