Posted on Jan 2, 2025, 5:24 am
#1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=210611
Manufacturer Reason for Recall: Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
FDA Determined 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).
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Manufacturer Reason for Recall: Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
FDA Determined 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).
Are weight bearing nails cursed?