Data Foundry

Medical device recalls 2015

Persona EM Distal Rod — Class II medical device recall Z-0411-2016

Terminated recall by Zimmer, Inc., reported 2015-12-16, distributed in AZ, CA, ID, IL, IN, KS, MA, MI…. Complaints that the ratchet teeth of the tube are not latching onto the rod.

Recall numberZ-0411-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer, Inc., Warsaw, IN, United States
Recall initiated2015-11-24
Classified2015-12-10
Reported by FDA2015-12-16
Terminated2017-03-24
DistributedAZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, WA
Countries outside the USDE
Quantity156
Lot numbers62137112, 62156914, 62222599
Model numbers42-5399-002-00, 62137112, 62156914, 62222599

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0411-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.