Surgify Halo Surgical Burr Breakage Risk During Spinal Surgery
Surgify Medical is recalling Surgify Halo 5.4 mm Medium surgical burrs due to potential burr breakage during bi-portal endoscopic spinal surgery. The device poses a risk of fragmentation that could complicate surgical procedures.
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 (burr breakage during surgery) where no reported illnesses or injuries are stated in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 5.4 mm, Medium (Model/Catalog Number 54.085.SHD.H1), a powered surgical burr used in spine surgery. The device has a potential to break during bi-portal endoscopic spinal surgery (BESS), which could result in burr fragments remaining in the surgical site and complicating the procedure.
All lots of this device are affected until the Instructions for Use (IFU) have been updated. The device was distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida.
Surgeons and surgical teams using this device should be aware of the breakage risk and take appropriate precautions. Patients who have undergone BESS procedures with this device and experience complications should consult their surgeon.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- device-breakage
- surgical-complication
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: 06429811532120
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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