Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-0

FDA device recall Z-0410-2016 · posted 2015-12-10 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LXH

Quantity affected

156

Distribution

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.

Date initiated

2015-11-24

Date posted

2015-12-10

Date terminated

2017-03-24

Location

Warsaw, IN