Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE
Summary
The FDA issued a Class II for Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight by NuVasive Specialized Orthopedics, Inc.. Reason: Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices..
Details
Source
Device Recall
External ID
Z-0500-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
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.
Lot/Code Info: 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)00195377151100(11)240223(17)290131(10)4021602AAA 4022005AAA (01)00195377151100(11)240222(17)290131(10)4022005AAA PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm 4021401AAA (01)00195377151216(11)240229(17)290131(10)4021401AAA PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm 4021524AAA (01)00195377151698(11)240219(17)290131(10)4021524AAA PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm 4021502AAA (01)00195377151803(11)240216(17)290131(10)4021502AAA 4021503AAA (01)00195377151803(11)240216(17)290131(10)4021503AAA PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm 4021203AAA (01)00195377151919(11)240215(17)290131(10)4021203AAA 4021921AAA (01)00195377151919(11)240227(17)290131(10)4021921AAA 4022010AAA (01)00195377151919(11)240301(17)290228(10)4022010AAA PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm 4021205AAA (01)00195377152022(11)240216(17)290131(10)4021205AAA 4021530AAA (01)00195377152022(11)240219(17)290131(10)4021530AAA 4022011AAA (01)00195377152022(11)240228(17)290131(10)4022011AAA PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm 4021902AAA (01)00195377152138(11)240222(17)290131(10)4021902AAA PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 265mm 4021404AAA (01)00195377151766(11)240221(17)290131(10)4021404AAA PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 280mm 4021501AAA (01)00195377151872(11)240219(17)290131(10)4021501AAA 4022626AAA (01)00195377151872(11)240304(17)290228(10)4022626AAA PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 305mm 4021407AAA (01)00195377151988(11)240216(17)290131(10)4021407AAA PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm 4021525AAA (01)00195377152572(11)240220(17)290131(10)4021525AAA 4022009AAA (01)00195377152572(11)240221(17)290131(10)4022009AAA PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm 4022623AAA (01)00195377152688(11)240301(17)290228(10)4022623AAA PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm 4022001AAA (01)00195377152909(11)240221(17)290131(10)4022001AAA
Quantity Affected: 164 devices
Reason for Recall
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
Distribution
U.S distribution to states of: FL and NV.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-30
Company
Aliso Viejo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NuVasive Specialized Orthopedics, Inc. has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NuVasive Specialized Orthopedics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NuVasive Specialized Orthopedics, Inc. have FDA actions?
NuVasive Specialized Orthopedics, Inc. has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0500-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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