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Terminated

Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.

FDA Recall Z-0411-2016 · Posted 2015-12-10

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2015-11-24
Date Terminated2017-03-24
Product Quantity156

Reason for Recall

Complaints that the ratchet teeth of the tube are not latching onto the rod.

Firm Action

Zimmer Biomet initiated a voluntary recall of the Persona EM Proximal Tube and Persona EM Distal Rod due to complaints that the ratchet teeth of the tube are not latching onto the rod via certified mail on 11/24/2015. The firm requests customers quarantine recalled devices, return the customer response forms, and assist in returning the devices to the Zimmer Biomet sales reps. Customers with questions may contact 1-800-348-2759 between 8:00 am and 8:00 pm EST.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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