Surgify Halo Surgical Burr Potential Breakage During Endoscopic Spinal Surgery
Surgify Medical is recalling Surgify Halo 3.0 mm Extendable surgical burrs because they may break during bi-portal endoscopic spinal surgery, posing a risk to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm product (potential burr breakage during surgery) with no reported illnesses or injuries stated in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (score 3).
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 3.0 mm, Extendable surgical burr (Model/Catalog Number: 30.000.SEE.U2) used in spinal surgery procedures.
The product may experience burr breakage during bi-portal endoscopic spinal surgery (BESS). Broken burr fragments could remain in the surgical site, potentially causing patient harm.
The recalled units are identified by UDI 06429811532229. All product lots are affected until an Instruction For Use (IFU) update has been implemented. The product has been distributed nationwide to facilities in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida.
Healthcare providers and facilities using this product should stop use and contact Surgify Medical OY. Patients who have undergone BESS procedures with this product should consult their healthcare provider if they experience any complications.
The recalled product
- Product
- Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- burr-breakage
- foreign-body-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 06429811532229
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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