Device product
DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.
Z-1278-2013
Product summary
- Event
- Event 64913
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 units
- Official record key
device-enforcement:Z-1278-2013
Official wording
Reason: Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
Code information: Lot number:13A01
Distribution pattern: Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions regarding this recall call 508-977-3813.
Derived failure modes
-
Unknown
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.