Recall Z-0500-2025 ยท HSB Rod, Fixation, Intramedullary And Accessories
NuVasive Specialized Orthopedics, Inc.
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 10.0
| Date | Nov 21, 2024 (initiated Sep 30, 2024) |
| Status | Open, Classified |
| Reason | Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices. |
| Root cause | Under Investigation by 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 se |
| Quantity | 164 devices |
| Distribution | U.S distribution to states of: FL and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232267 | Precice Max System Nuvasive Specialized Orthopedics, Incorporated, Dec 15, 2023 |