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PROFILE PLUS RESTERILIZABLE SIZERS (2015-08-19)
- Starting date:
- August 19, 2015
- Posting date:
- September 1, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54868
Affected Products
- MODERATE PROFILE PLUS RESTERILIZABLE
- HIGH PROFILE RESTERILIZABLE SIZER
Reason
A previously discontinued Health Canada licensed Mentor Non-Sterile Gel Breast Implant sizer was incorrectly distributed to several customers in Canada when the customer order was for the sterile version of the same product. The sterile version of the product is licensed with Health Canada.
Affected products
A. MODERATE PROFILE PLUS RESTERILIZABLE
Lot or serial number
>10 NUMBERS, CONTACT MFR
Model or catalog number
- RSZ-2751
- RSZ-3251
- RSZ-4001
- RSZ-4251
- RSZ-4751
- RSZ-5251
- RSZ-5751
- RSZ-6501
Companies
- Manufacturer
-
Mentor
3041 Skyway Circle North
Irving
75038
Texas
UNITED STATES
B. HIGH PROFILE RESTERILIZABLE SIZER
Lot or serial number
- 6406134
- 6434505
- 6492914
- 6571808
- 6623189
- 6652667
- 6656806
- 6657792
- 6659170
- 6665665
Model or catalog number
- RSZ-4754
- RSZ-7504
Companies
- Manufacturer
-
Mentor
3041 Skyway Circle North
Irving
75038
Texas
UNITED STATES