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Premier and Atlantis Anterior Cervical Plate System Self-Tapping Screw Modules ("Screw Caddy")
- Starting date:
- October 3, 2012
- Posting date:
- October 29, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15151
Recalled Products:
- Premier Anterior Cervical Plate System Self-Tapping Screw Module ("Screw Caddy")
- Atlantis Anterior Cervical Plate System Self-Tapping Screw Module ("Screw Caddy")
Reason
It was discovered that the measurement gauge located on the lower, left side of the caddy may be out of specification, which could cause a screw to be measured incorrectly. An incorrect gauge could measure a screw to be approximately 1 mm shorter than it actually is.
Affected products
A. Premier Anterior Cervical Plate System Self-Tapping Screw Module ("Screw Caddy")
Lot or serial number
All Lots
Model or catalog number
- 176-503
- 176-504
- 176-513
- 976-516
Companies
- Manufacturer
-
Medtronic SOFAMOR Danek USA, Inc.
B. Atlantis Anterior Cervical Plate System Self-Tapping Screw Module ("Screw Caddy")
Lot or serial number
1860503
Model or catalog number
All Lots
Companies
- Manufacturer
-
Medtronic SOFAMOR Danek USA, Inc.