Product Wiki · Recalls · Health Canada — Medical Devices

Trinica ALP System Case Assembly (2013-10-10) — recall 50547

Health Canada — Medical Devices · Canada · 2013-10-25 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
50547
Date of alert
2013-10-25
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: Zimmer is initiating a device correction for the Trinica anterior lumbar plate (ALP) system case assembly. The ratchet handles, Part Number 07.00438.001, may not be effectively sterilized if left in their designated location(s) in the instrument tray. This is due to the current bracketing in the tray which may interfere with complete steam penetration into the cannulated handle. To assure effective sterilization, the ratchet handles must be sterilized external to the instrument tray until newly designed replacement trays are available.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/trinica-alp-system-case-assemb

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