FDA Device recall Z-0410-2016
Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Pers…
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Pers… by Zimmer, citing complaints that the ratchet teeth of the tube are not latching onto the rod.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0410-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-24 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, WA |
Product
Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
Reason
Complaints that the ratchet teeth of the tube are not latching onto the rod.
Identifiers
| code_info | Proximal Tube Item Number 42-5399-001-00, Lots: 2137111, 62156913, 62222598. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0410-2016%22
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