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Various Zimmer Dental Products (2017-08-02)
- Starting date:
- August 2, 2017
- Posting date:
- September 5, 2017
- 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-64416
Affected Products
- Tapered Screw-Vent Gold Abutments
- Zimmer Dental One-Piece Implant
- Thread Retriever Drill And Guide Sleeves
- Abutment Try-In, Contour
- Waxing Coping, Contour
Reason
Zimmer Dental is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard instructions for use (IFUs). All listed products were missing supplemental IFUs. Affected customers are being provided with instructions on how to obtain the supplemental IFUs from the website ifu.zimmerdental.com or by contacting Zimmer's e-labeling services section.
Affected products
A. Tapered Screw-Vent Gold Abutments
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
- HLA3G
- HLA4G
- HLA5G
- NEA3G
- NEA4G
Companies
- Manufacturer
-
Zimmer Dental Inc.
1900 Aston Avenue
Carlsbad
92008
California
UNITED STATES
B. Zimmer Dental One-Piece Implant
Lot or serial number
- 61378631
- 62899245
- 63409322
Model or catalog number
ZOP30S10
Companies
- Manufacturer
-
Zimmer Dental Inc.
1900 Aston Avenue
Carlsbad
92008
California
UNITED STATES
C. Thread Retriever Drill And Guide Sleeves
Lot or serial number
- 63241114
- 63321266
- 63426542
- 63426543
- 63503028
Model or catalog number
- 2223
- 2224
Companies
- Manufacturer
-
Zimmer Dental Inc.
1900 Aston Avenue
Carlsbad
92008
California
UNITED STATES
D. Abutment Try-In, Contour
Lot or serial number
63145351
Model or catalog number
ZOAT34
Companies
- Manufacturer
-
Zimmer Dental Inc.
1900 Aston Avenue
Carlsbad
92008
California
UNITED STATES
E. Waxing Coping, Contour
Lot or serial number
- 62602470
- 63135399
- 63155008
- 63240239
- 63254023
- 63331292
- 63432495
Model or catalog number
- ZOCWAX3S
- ZOCWAX4S
Companies
- Manufacturer
-
Zimmer Dental Inc.
1900 Aston Avenue
Carlsbad
92008
California
UNITED STATES