IVS BONE CEMENT (2017-10-18)

IVS BONE CEMENT (2017-10-18) - Recalls and safety alerts
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

IVS BONE CEMENT

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.

 

All lots

  • 2101-0000
  • 2101-0002
  • 2101-0105
  • 2101-0110
Manufacturer

Orthovita Inc.,
45 Great Valley Parkway,
Malvern
19355
Pennsylvania
UNITED STATES

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