Reported May 24, 2017 · Terminated
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…
Aesculap Implant Systems LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
13 of 13 products
| # | Product as published |
|---|---|
| 1 | GE426R |
| 2 | HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM |
| 3 | GE426SU |
| 4 | HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM |
| 5 | GE526R |
| 6 | HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM |
| 7 | GE526SU |
| 8 | HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5 |
| 9 | GE626R |
| 10 | HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM |
| 11 | GE626SU |
| 12 | HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5 |
| 13 | 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. |
- Lot codes and dates
- Model numbers
GE426RGE426SUGE526RGE526SUGE626RGE626SU
- Model numbers
- Amount recalled
- total amount of burrs - 608
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Aesculap Implant Systems LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.