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Open, Classified

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.

FDA Recall Z-0500-2025 · Posted 2024-11-21

Recalling FirmNuVasive Specialized Orthopedics, Inc.
Recall StatusOpen, Classified
Product CodeHSB
Date Initiated2024-09-30
Product Quantity164 devices

Reason for Recall

Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

Firm Action

On 9/30/2024, the firm sent an "URGENT: Medical Device Recall Notification" letter via FedEx to customers informing them that Globus Medical is investigating potential issues with the design, manufacturing, and documentation related to the validation associated with the Precice Max manufactured by NuVasive Specialized Orthopedics (NSO). Customers are instructed to: Monitor their patients closely for any potential adverse events and to stop/cease use of device that have not been implanted and immediately return all remaining Precice" Max devices and complete the attached Response Form and send it by FAX: 1-610-300-1342 or Email:[email protected]. Contact Globus Customer Service at 1-866-456-2871 for Return Authorization. Contact your local Globus Sales Representative to coordinate the return of the Precice Max Device(s). For recall related questions and support contact: Globus Medical Complaint Handling Unit by Fax: 610-300-1342 or Email: [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

U.S distribution to states of: FL and NV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated · 2023-12-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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