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Trilogy Bone Screws, 6.5mm x 35mm & 25mm (2014-11-26)
- Starting date:
- November 26, 2014
- Posting date:
- December 4, 2014
- 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-42717
Recalled Products
Trilogy Bone Screws, 6.5mm x 35mm & 25mm
Reason
Zimmer is initiating a recall of selected lots of 25mm and 35mm length trilogy bone screws due to fracture during insertion. Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of fractures.
Affected products
Trilogy Bone Screws, 6.5mm x 35mm & 25mm
Lot or serial number
62748089
62784622
62793494
62793495
62793501
62793503
62818709
Model or catalog number
6250-65-25
6250-65-35
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES