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.
FDA Recall Z-1278-2013 · Posted 2013-05-09
Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
Recall StatusTerminated
Product CodeNBH
Date Initiated2013-04-15
Date Terminated2016-03-11
Product Quantity27 units
Reason for Recall
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
Firm Action
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.
Root Cause
Process control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.