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Standard Offset Cup Impactors (2014-03-28)
- Starting date:
- March 28, 2014
- Posting date:
- September 9, 2014
- 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-41305
Recalled Products
Standard Offset Cup Impactors
Reason
Greatbatch has determined that when a Standard Offset Cup Impactors is sterilized per the current instructions for use (IFU), the device may not be sterile. Similarly, if the device is removed from the sterilizer after being sent through steam sterilization per the IFU provided, it might not remain sterile because it is not completely dry.
Affected products
Standard Offset Cup Impactors
Lot or serial number
Not applicable
Model or catalog number
- 2999-60-834
- 2999-60-834
- 2999-63-518
- 2999-63-518
- E119814
- E119814
Companies
- Manufacturer
-
Greatbatch Medical
4545 Kroemer Road
Fort Wayne
46818
Indiana
UNITED STATES