Z-2089-2017Class II

Ge426r; Hi-Line Xs Diamond Burr X-Crs.i D4.5mm; Ge426su; Hi-Line Xs Disp.diam.burr X-Crs.i D4.5mm; Ge526r...

Name: Z-2089-2017 Ge426r; Hi-Line Xs Diamond Burr X-Crs.i D4.5mm; Ge426su; Hi-Line Xs Disp.diam.burr X-Crs.i D4.5mm; Ge526r...
Creator: Aesculap Implant Systems LLC
Published: 2017-03-28
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2017-03-28 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of 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... on 2017-03-28. FDA classified it as Class II and gives the reason as "Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2089-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-28
Posted: 2017-04-24
Terminated: 2018-02-06
Recalling firm: Aesculap Inc
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 XS DISP.DIAM.BURR X-CRS.III D4.5; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Product code: GEY Motor, Surgical Instrument, Ac-Powered
Reason for recall: Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 7, 2017 8 Hospitals, 3 distributors and 11 sales reps were sent an Urgent Medical Device Recall Notification letter. Letters were sent UPS overnight. Customers were asked to immediately discontinue use and return the product to Aesculap, Inc.
Quantity in commerce: total amount of burrs - 608
Distribution: US Nationwide distribution - CA, IL, NY, PA, TN, TX
Product codes and lots: Model numbers: GE426R ; GE426SU ; GE526R ; GE526SU ; GE626R ; GE626SU ;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2089-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2087-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12
Z-2088-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12
Z-2089-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12

Product code GEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)