SURGIFY MEDICAL OY — Class II: Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & acce
Surgify Medical Oy has initiated a Class II recall for the Surgify Halo (5.4 mm, Medium, Model 54.085.SHD.H1) due to the potential for burr breakage during bi-portal endoscopic spinal surgery (BESS).
This recall affects Surgify Medical Oy and healthcare facilities utilizing simple, powered burrs and trephines in endoscopic spinal procedures.
The mechanical failure of a surgical burr during spinal surgery presents a risk of retained foreign bodies or unintended tissue trauma. This suggests a potential need for the manufacturer to re-evaluate material specifications or durability testing under the specific mechanical stresses of the BESS technique. Regulatory teams may need to assess if existing risk files adequately captured this failure mode.
Quality and clinical departments should review surgical technique guides and risk assessments related to bi-portal endoscopic spinal surgery. Affected inventories of model 54.085.SHD.H1 should be identified and handled according to the firm's recall procedure and CAPA framework.
Class II. Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).. Product: Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered). Firm: SURGIFY MEDICAL OY (Espoo N/A Finland). Status: Ongoing.
Open in openFDA / FDA.gov