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RE-STERILIZABLE SIZER INSPIRA MP (2017-11-15)
- Starting date:
- November 15, 2017
- Posting date:
- November 30, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-65262
Affected products
RE-STERILIZABLE SIZER INSPIRA MP
Reason
The fill volume information (black stamp) printed on the NATRELLE Re-sterilizable breast implant sizers incorrectly states 345cc and does not coincide with the correct fill volume information printed on the device labels and the embossed product patch (375cc).
Affected products
RE-STERILIZABLE SIZER INSPIRA MP
Lot or serial number
20741120
20741121
20741122
20741123
Model or catalog number
N-SZRM375
Companies
- Manufacturer
-
ALLERGAN
MARLOW INTERNATIONAL, PARKWAY
MARLOW, BUCKINGHAMSHIRE,
SL7 1YL
UNITED KINGDOM