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M/DN Intramedullary 4.5MM Diameter Screws (2015-05-04)
- Starting date:
- May 4, 2015
- Posting date:
- June 1, 2015
- 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-53571
Recalled Products
- M/DN Intramedullary 4.5MM Diameter Screws
Reason
Zimmer is initiating a recall of M/DN Intramedullary Fixation 4.5mm Diameter Cortical Screws listed as COMP17IBLE with the M/DN system as it was found through review of the design history files that they are not compatible with the M/DN system. The compatibility issue can only occur at worst case print specification wherein multiple features are at maximum material condition (meaning the hole in the nail would need to be as small as possible and the outside diameter of the screw would need to be as large as possible).
Affected products
A. M/DN Intramedullary 4.5MM Diameter Screws
Lot or serial number
All lots.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES