Precice Max Orthopedic Implants Recalled for Design and Manufacturing Validation Issues
NuVasive Specialized Orthopedics is recalling 164 Precice Max orthopedic implants distributed to Florida and Nevada due to potential design, manufacturing, and documentation validation issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II precautionary recall with no reported injuries or illnesses. The hazard is theoretical and incompletely specified in the source text, relating to validation and documentation issues rather than a clearly identified functional defect.
Plain-English summary
NuVasive Specialized Orthopedics, Inc. is recalling 164 Precice Max orthopedic implants due to potential issues with design, manufacturing, and documentation related to product validation.
The Precice Max Nail is an orthopedic device intended to stabilize fractures, nonunions, and malunions of the femur, tibia, and humerus, and to provide magnetically controlled lengthening of long bones. The recall was issued due to design, manufacturing, and documentation issues related to validation of the affected devices.
The recalled devices were distributed to Florida and Nevada. Affected devices have specific lot numbers and part numbers identified by the FDA.
Patients with these implants should contact their orthopedic surgeon. Healthcare providers should verify whether implants in their patients match the recalled lot and part numbers, and consult the FDA notice for further guidance on patient management.
The recalled product
- Product
- 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 PREC
- Manufacturer
- NuVasive Specialized Orthopedics, Inc.
- Hazard
- design-defect
- manufacturing-defect
- documentation-issue
Distribution
Distributed in 2 states:
- FL
- NV
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