The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.
FDA Recall Z-0123-2015 · Posted 2014-10-23
Advertisement
Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-10-07
Date Terminated2015-09-23
Product Quantity618 units
Reason for Recall
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Firm Action
Zimmer sent an " URGENT MEDICAL DEVICE RECALL - LOT SPECIFIC " notifications dated September 2014, to all affected customers.
The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement