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TI Button Plate 7 Holes (2016-07-18)
- Starting date:
- July 18, 2016
- Posting date:
- July 29, 2016
- 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-59624
Affected products
A. TI Button Plate 7 Holes
Reason
The DePuy Synthes button plate(s) were distributed with a package insert containing incorrect MR safety information that does not meet the current ASTM standard. In 2008 standard method ASTM F2503 standard practice for marking medical devices and other items for safety in the magnetic resonance environment was revised. The Synthes button plate was labelled as MR safe, per the ASTM standard metallic devices are no longer identified as MR safe.
Affected products
A. TI Button Plate 7 Holes
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
482.823
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES