PlainRecalls
FDA Devices Moderate Class II 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.

Reported: December 16, 2015 Initiated: November 24, 2015 #Z-0411-2016

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Zimmer, Inc.
Units 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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zimmer, Inc.. Units affected: 156.
Why was this product recalled?
Complaints that the ratchet teeth of the tube are not latching onto the rod.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 16, 2015. Severity: Moderate. Recall number: Z-0411-2016.