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IVS BONE CEMENT (2017-10-18)
- Starting date:
- October 18, 2017
- Posting date:
- October 27, 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-64974
Affected products
IVS BONE CEMENT
Reason
Earlier this year, the FDA initiated an industry-wide action asking all companies that sell bone cement to include warnings about the potential for cardiac embolism in their IFUs. This update was not initiated by any specific incident. All us companies that make/sell bone cement were asked to update their IFUs.
Affected products
IVS BONE CEMENT
Lot or serial number
All lots
Model or catalog number
- 2101-0000
- 2101-0002
- 2101-0105
- 2101-0110
Companies
- Manufacturer
-
Orthovita Inc.,
45 Great Valley Parkway,
Malvern
19355
Pennsylvania
UNITED STATES