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Kryptonite Bone Cement (May 02, 2012)
- Starting date:
- May 02, 2012
- Posting date:
- May 14, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73589
Reason
Recent testing has confirmed that strength and stiffness of the bone cement decreases by approximately half when the testing is conducted at body temperature. Preclinical testing was conducted at ambient temperature.
Affected products
Kryptonite Bone Cement(2012-05-02)
Lot or serial number
All lots
Model or catalog number
52-702-05-04, 52-702-10-04, KRYP-Z-03, KRYP-X-03, KRYP-X-05, KRYP-X-10, KRYP-Z-05, KRYP-Z-10
Companies
- Manufacturer
- Not Applicable
- Date modified: