Product Wiki · Recalls · Health Canada — Medical Devices

TRIDENT CONSTRAINED LINER IMPACTOR TIPS (2016-06-06) — recall 55118

Health Canada — Medical Devices · Canada · 2016-06-24 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55118
Date of alert
2016-06-24
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/trident-constrained-liner-impa

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