Z-0411-2016 Class II Terminated
FDA device recall Z-0411-2016 was initiated by Zimmer, Inc. on Nov 24, 2015 and is designated Class II. Reason for recall: Complaints that the ratchet teeth of the tube are not latching onto the rod. The recall status is terminated (terminated Mar 24, 2017). Affected quantity: 156.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 16, 2015
- Initiation Date
- Nov 24, 2015
- Termination Date
- Mar 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 156
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.
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.
Code Information
Distal Rod Item Number 42-5399-002-00 Lots: 62137112, 62156914, 62222599.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0411-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026