The North American Spine Society is committed to quality patient care through promotion of patient safety and prevention of medical errors.
NASS monitors a variety of government and other resources for patient safety related notices that may be useful to our members. Information
from these notices is also archived on the NASS website at https://www.spine.org/Pages/ResearchClinicalCare/PatientSafety/SpineSafetyAlerts.
aspx. This information is provided as a service for information and education only.
Spine Safety Notices
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s
Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 at: www.fda.gov/medwatch/getforms.htm.
Mail to address on the pre-addressed form.
• Fax: (800) FDA-0178
DRUG/DEVICE/OTHER NOTIFICATION TYPE FULL REPORT:
Zimmer Biomet | SpF PLUS-Mini and SpF XL IIB Implantable
Class I Recall: Potential for Harmful
Codeine and Tramadol Medicines Drug Safety Communication: Restricted
Use in Children; Recommended Against
Use in Breastfeeding Women
Isomeric Pharmacy | Sterile Compounded Products Recall: Lack of Sterility Assurance https://goo.gl/zF7Lfu
Gadolinium-based Congrast Agents for Magnetic Resonance
Drug Safety Communication: No Harmful
Effects Identified with Brain Retention
Alert Warning Cautionary Notice
(High Impact) (Moderate impact) (Low Impact)
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