Statis Connex Handpiece Couplers, SANAO Dental Handpieces, Statis ML201.1/ SL101.1 (2019-02-28)
- Starting date:
- February 28, 2019
- Posting date:
- April 5, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69488
Last updated: 2019-04-05
Affected Products
- Statis Connex Handpiece Couplers
- SANAO Dental Handpieces
- Statis ML201.1
- Statis SL101.1
Reason
This recall is being initiated because the manufacturer has recently decided not to maintain the Canadian Medical Device licenses for these products due to the new MDSAP requirements in Canada. The licenses have now been cancelled and these products can no longer be sold in Canada. The safety and effectiveness are not affected and product that has already been sold to customers is not affected by this recall.
Affected products
A. Statis Connex Handpiece Couplers
Lot or serial number
Not applicable.
Model or catalog number
- S10010
Companies
- Manufacturer
-
SycoTec GmbH & Co.KG
Wangener Str. 78
Leutkirch
GERMANY
B. SANAO Dental Handpieces
Lot or serial number
Not applicable.
Model or catalog number
- S20100
- S20101
- S20102
- S20103
- S20104
- S20105
- S20106
- S20107
Companies
- Manufacturer
-
SycoTec GmbH & Co.KG
Wangener Str. 78
Leutkirch
GERMANY
C. Statis ML201.1
Lot or serial number
Not applicable.
Model or catalog number
- S10000
Companies
- Manufacturer
-
SycoTec GmbH & Co.KG
Wangener Str. 78
Leutkirch
GERMANY
D. Statis SL101.1
Lot or serial number
Not applicable.
Model or catalog number
- S10001
Companies
- Manufacturer
-
SycoTec GmbH & Co.KG
Wangener Str. 78
Leutkirch
GERMANY