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Dental Composite (2016-03-02)
- Starting date:
- March 2, 2016
- Posting date:
- April 7, 2016
- 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-57850
Affected products
A. XRV Herculite UNIDOSE
B. Point 4
C. Herculite Ultra XL - UNIDOSE
D. Herculite Ultra Enamel - UNIDOSE
E.Herculite Ultra Dentin - UNIDOSE
F. Herculite Ultra Light Incisal - UNIDOSE
G. Premise UNIDOSE
H. Premise UNIDOSE OPAQUE
I. Premise UNIDOSE TRANSLUCENT
Reason
The production process used to package the affected lots may lead to the presence of plastic particulates in the dental composite material. The particulate is unlikely to cause any adverse health consequences.
Affected products
A. XRV Herculite UNIDOSE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
29835
29836
29837
29838
29839
29840
29841
29842
29843
29844
29845
29846
29847
29848
29849
29850
29851
29852
29853
29854
29855
29856
29857
29858
29859
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES
B. Point 4
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
29898
29899
29900
29901
29902
29903
29904
29905
29906
29907
29908
29909
29910
29911
29912
29913
29914
29915
29916
29917
29918
29919
31368
31369
31370
31372
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES
C. Herculite Ultra XL - UNIDOSE
Lot or serial number
34346
Model or catalog number
34346
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES
D. Herculite Ultra Enamel - UNIDOSE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
34347
34348
34349
34350
34351
34448
34776
34777
34778
34779
34780
35159
35160
35161
35162
35166
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES
E.Herculite Ultra Dentin - UNIDOSE
Lot or serial number
34352
34353
35163
Model or catalog number
34352
34353
35163
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES
F. Herculite Ultra Light Incisal - UNIDOSE
Lot or serial number
34354
Model or catalog number
34354
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES
G. Premise UNIDOSE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
32650
32651
32652
32653
32654
32655
32656
32657
32658
32659
32660
32661
32662
32663
32664
32665
32666
32667
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES
H. Premise UNIDOSE OPAQUE
Lot or serial number
32668
32669
32670
32671
32672
32673
32674
32675
Model or catalog number
32668
32669
32670
32671
32672
32673
32674
32675
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES
I. Premise UNIDOSE TRANSLUCENT
Lot or serial number
32676
32677
32678
Model or catalog number
32676
32677
32678
32679
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES