Recall Z-1278-2013— DePuy Mitek, Inc., a Johnson & Johnson Co.
Class II · Terminated
Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2013-04-15, terminated 2016-03-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration..
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-15
- Terminated
- 2016-03-11
- Firm location
- Raynham, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.