Z-0411-2016Class II

Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item...

Name: Z-0411-2016 Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item...
Creator: Zimmer, Inc.
Published: 2015-11-24
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-11-24 / Terminated

FDA source

Zimmer, Inc. began a recall of 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... on 2015-11-24. FDA classified it as Class II and gives the reason as "Complaints that the ratchet teeth of the tube are not latching onto the rod". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0411-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-24
Posted: 2015-12-10
Terminated: 2017-03-24
Recalling firm: Zimmer GmbH
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Complaints that the ratchet teeth of the tube are not latching onto the rod.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 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.
Product codes and lots: Distal Rod Item Number 42-5399-002-00 Lots: 62137112, 62156914, 62222599.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0411-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0410-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-10
Z-0411-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-10

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)