Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX
FDA device recall Z-0500-2025 · posted 2024-11-21 · Open, Classified
Recall details
- Recalling firm
- NuVasive Specialized Orthopedics, Inc.
- Reason for recall
- Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
- Action taken
- 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:recall@globusmedical.com. 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: recall@globusmedical.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 164 devices
- Distribution
- U.S distribution to states of: FL and NV.
- Date initiated
- 2024-09-30
- Date posted
- 2024-11-21
- Location
- Aliso Viejo, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Precice Max System (K232267) | Nuvasive Specialized Orthopedics, Incorporated | 2023-12-15 |