The Recall Desk
HighFDA (Devices)·Z-2089-2017·Announced 2017-05-24

Aesculap Hi-Line XS Diamond Burrs Recalled for Particulate Breakage Risk

Aesculap Implant Systems LLC is recalling 608 Hi-Line XS Diamond Burrs because diamond particulates may break off and fall into the surgical site, potentially causing foreign body reactions or soft tissue damage.

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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (foreign body reaction and soft tissue damage) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Aesculap Implant Systems LLC is recalling 608 units of Hi-Line XS Diamond Burrs, including models GE426R, GE426SU, GE526R, GE526SU, GE626R, and GE626SU. These medical devices are intended for high-speed cutting, sawing, drilling, and manipulation of soft tissue and bone in Spine, ENT, Neuro, and Maxillofacial Surgery.

The recall is due to a risk that diamond particulates may break off the burr and fall into the surgical site. If these particles are not detected and removed, they may cause a foreign body reaction or mechanically induced soft tissue damage.

The affected products were distributed nationwide in the United States, specifically in California, Illinois, New York, Pennsylvania, Tennessee, and Texas. Healthcare facilities and users should stop using the affected burrs and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Surgical Instruments
Hazard
Affected units
608

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 (6)

  • Model numbers: GE426R
  • GE426SU
  • GE526R
  • GE526SU
  • GE626R
  • GE626SU

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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