CLASS II Device recall · Reported 16 Dec 2015 · FDA Enforcement Report

Persona EM Proximal Tube, orthopedic manual surgical recalled by Zimmer

Zimmer is recalling Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee, distributed in 19 states. The recall was initiated on 24 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProximal Tube Item Number 42-5399-001-00, Lots: 2137111, 62156913, 62222598.

Quantity recalled156

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0410-2016
FDA event ID: 72714
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 24 Nov 2015
FDA classified: 10 Dec 2015
Reported: 16 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

24 Nov 2015	Recall initiated by company
10 Dec 2015	Classified by FDA	+16 days
16 Dec 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Arizona California Idaho Illinois Indiana Kansas Massachusetts Michigan Minnesota Missouri North Carolina New Jersey New York Ohio Pennsylvania Tennessee Texas Virginia Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Proximal Tube Item Number 42-5399-001-00, Lots: 2137111, 62156913, 62222598.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 72714

This product is part of a recall event; the main page for the event is Persona EM Distal Rod, orthopedic manual surgical recalled by Zimmer.

Reported	Class	Recall	Company	Reason	Where
16 Dec 2015	CLASS II	Persona EM Distal Rod, orthopedic manual surgical recalled by Zimmer	Zimmer	Other	19 states

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