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Trinica ALP System Case Assembly (2013-10-10)
- Starting date:
- October 10, 2013
- Posting date:
- October 25, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36401
Recalled products
A. Trinica ALP System Case Assembly
Reason
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.
Affected products
A. Trinica ALP System Case Assembly
Lot or serial number
- P061255
Model or catalog number
- 07.01058.001
Companies
- Manufacturer
-
Zimmer Spine, Inc.
7375 Bush Lake Road
Minneapolis
55439
Minnesota
UNITED STATES