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TRIDENT CONSTRAINED LINER IMPACTOR TIPS (2016-06-06)
- Starting date:
- June 6, 2016
- Posting date:
- June 24, 2016
- 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-59024
Affected products
A. TRIDENT CONSTRAINED LINER IMPACTOR TIPS
Reason
During steam sterilization validation it was discovered that the TRIDENT Constrained Liner Impactor Tips do not meet the required Sterility Assurance Level (SAL) of 10-6. Please note that these instruments are sterilized at the hospital prior to surgery, however, and do not come from Stryker sterile.
Affected products
A. TRIDENT CONSTRAINED LINER IMPACTOR TIPS
Lot or serial number
All lots
Model or catalog number
- 2199-2022
- 2199-2028
- 2199-2032
Companies
- Manufacturer
-
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
New Jersey
UNITED STATES