SURGIFY MEDICAL OY — Class II: Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trep
Surgify Medical OY has initiated a Class II recall for the Surgify Halo, 4.0 mm, Extendable (Model 40.000.SEE.H1) due to potential burr breakage during bi-portal endoscopic spinal surgery (BESS). The recall is currently categorized as ongoing.
Surgify Medical OY, spinal surgeons specializing in bi-portal endoscopic techniques, hospital sterile processing departments, and quality/regulatory departments responsible for powered surgical instrumentation.
This recall highlights a specific mechanical failure risk associated with high-precision burrs used in specialized spinal procedures. The designation of 'Class II' suggests that while the risk of serious injury or death may be remote, the potential for device failure during surgery necessitates immediate corrective action. Regulatory teams may need to investigate whether this is a localized manufacturing defect or a broader design limitation when the extendable model is used in BESS procedures.
QA and supply chain teams should immediately identify and quarantine affected lots of the 4.0 mm Extendable Surgify Halo. Regulatory and clinical teams should evaluate the risk of burr breakage in specific surgical contexts (e.g., BESS) and update customer instructions or safety communications as required.
Class II. Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).. Product: Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered). Firm: SURGIFY MEDICAL OY (Espoo N/A Finland). Status: Ongoing.
Open in openFDA / FDA.gov