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.
This recall has been terminated (originally issued May 9, 2013).
- Recall Initiated
- April 15, 2013
- Posted
- May 9, 2013
- Terminated
- March 11, 2016
- Recall Number
- Z-1278-2013
- Quantity
- 27 units
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
Distribution
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.
Lot / Code Info
Lot number:13A01
Root Cause
Process control
Action Taken
DePuy Synthes sent an Urgent Voluntary Product Recall letter dated April 15, 2013, to all affected customers. The letter iidentified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check all inventories to locate and return the affected product. For returns customers were instructed call 1-877-379-4871 to obtain a goods authorization (RGA) number. Affected product should be returned to: Mitek Sports Medicine ATTN: Mitek Complaints 325 Paramouont Drive Rayham, MA 02067 For questions customers were instructed to call 1-877-379-4871.