FDA Medical devices recall ·
Precice Max recall
- Recall number
- Z-0500-2025
- Date
- (initiated September 30, 2024)
- Company / brand
- NuVasive Specialized Orthopedics, Inc.
101 Enterprise Ste 100, Aliso Viejo, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 164 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 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 was it recalled?
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part Number: PM10.0-80B265 UDI codes: (01)00195377150929(11)240223(17)290131(10)4021504AAA (01)00195377150929(11)240301(17)290228(10)4022214AAA Lot Numbers: 4021504AAA 4022214AAA Part Number: PM10.0-80B280 UDI codes: (01)00195377151032(11)240222(17)290131(10)4021505AAA (01)00195377151032(11)240220(17)290131(10)4021903AAA Lot Numbers: 4021505AAA 4021903AAA Part Number: PM10.0-80B305 UDI Codes: (01)00195377151148(11)240214(17)290131(10)4021217AAA (01)00195377151148(11)240220(17)290131(10)4021901AAA (01)00195377151148(11)240304(17)290228(10)4022131AAA Lot Numbers: 4021217AAA 4021901AAA 4022131AAA PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm 4021218AAA (01)00195377151254(11)240215(17)290131(10)4021218AAA 4021910AAA (01)00195377151254(11)240221(17)290131(10)4021910AAA 4022301AAA (01)00195377151254(11)240304(17)290228(10)4022301AAA 4022625AAA (01)00195377151254(11)240301(17)290228(10)4022625AAA PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm 4022135AAA (01)00195377151360(11)240304(17)290228(10)4022135AAA 4022136AAA (01)00195377151360(11)240223(17)290131(10)4022136AAA PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm 4021307AAA (01)00195377150998(11)240219(17)290131(10)4021307AAA 4021926AAA (01)00195377150998(11)240221(17)290131(10)4021926AAA PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm 4021314AAA (01)00195377151100(11)240215(17)290131(10)4021314AAA 4021602AAA (01)001953
Distribution
U.S distribution to states of: FL and NV.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0500-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.