Z-1278-2013 Class II Terminated
FDA device recall Z-1278-2013 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Apr 15, 2013 and is designated Class II. Reason for recall: Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. The recall status is terminated (terminated Mar 11, 2016). Affected quantity: 27 units.
Recall details
- Product Type
- Devices
- Report Date
- May 15, 2013
- Initiation Date
- Apr 15, 2013
- Termination Date
- Mar 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Product description
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.
Reason for recall
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
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.
Code information
Lot number:13A01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1278-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026