CLASS II Device recall · Reported 24 May 2017 · FDA Enforcement Report
Ge426r; Hi-line Xs Diamond Burr X-crs.i D4.; Ge426su recalled
Aesculap Implant Systems is recalling Ge426r; Hi-line Xs Diamond Burr X-crs.i D4.; Ge426su; Hi-line Xs Disp.diam.burr X-crs.i, distributed nationwide in the US. The recall was initiated on 28 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2089-2017
- FDA event ID
- 76988
- Recalling firm
- Aesculap Implant Systems, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Mar 2017
- FDA classified
- 12 May 2017
- Reported
- 24 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Spinal Implants
Timeline
| 28 Mar 2017 | Recall initiated by company | |
| 12 May 2017 | Classified by FDA | +45 days |
| 24 May 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution - CA, IL, NY, PA, TN, TX
Nationwide CaliforniaIllinoisNew YorkPennsylvaniaTennesseeTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model numbers: GE426R ; GE426SU ; GE526R ; GE526SU ; GE626R ; GE626SU ;
Where was it sold?
US Nationwide distribution - CA, IL, NY, PA, TN, TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 76988| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Gp321r; Elan 4 2-ring Diamond Burr Coarse D2.3; Gp322r recalled | Aesculap Implant Systems | Particulate Matter | Nationwide | |
| CLASS II | Gp161r; Elan 4 1-ring Diamond Burr Coarse D2.0; Gp162r recalled | Aesculap Implant Systems | Particulate Matter | Nationwide |
More recalls from Aesculap Implant Systems
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | For intraventricular recalled by Aesculap Implant Systems | Aesculap Implant Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Aesculap Surgical Needle, straight, 3 1/2", width recalled | Aesculap Implant Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Aesculap Caiman Articulating D5 recalled by Aesculap Implant Systems | Aesculap Implant Systems | Other | Nationwide |
| Device | CLASS II | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only recalled | Aesculap Implant Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Aesculap Ennovate Set Screw Sterile-implants are used recalled | Aesculap Implant Systems | Packaging Defects | GA, TX |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |