CLASS II Device recall · Reported 17 Oct 2018 · FDA Enforcement Report

Verasense for Zimmer Biomet Persona CR G-H/7-12 Left recalled

Orthosensor is recalling Verasense for Zimmer Biomet Persona CR G-H/7-12 Left, distributed in 7 states. The recall was initiated on 12 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 20549, 20565, 20606, 20610, 20615, UDI 00816818021454.

Quantity recalled84 devices

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-0086-2019
FDA event ID: 80845
Recalling firm: Orthosensor, Dania, FL
Classification: Class II
Status: Terminated
Recall initiated: 12 Jul 2018
FDA classified: 5 Oct 2018
Reported: 17 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 Jul 2018	Recall initiated by company
5 Oct 2018	Classified by FDA	+85 days
17 Oct 2018	Published in enforcement report	+12 days

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

Reason for recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.

Where it was distributed

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

California Florida Illinois Indiana Michigan North Carolina New York

Questions about this recall

Why was it recalled?

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Which lots are affected?

Lot numbers 20549, 20565, 20606, 20610, 20615, UDI 00816818021454.

Where was it sold?

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

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

5 other products · FDA event 80845

This product is part of a recall event; the main page for the event is Verasense for Zimmer Biomet Persona CR E-F/3-11 Left recalled.

Reported	Class	Recall	Company	Reason	Where
17 Oct 2018	CLASS II	Verasense for Zimmer Biomet Persona CR E-F/3-11 Left recalled	Orthosensor	Device Malfunction	7 states
17 Oct 2018	CLASS II	Verasense for Zimmer Biomet Persona CR G-H/7-12 Right recalled	Orthosensor	Device Malfunction	7 states
17 Oct 2018	CLASS II	Verasense for Zimmer Biomet Persona CR E-F/3-11 Right recalled	Orthosensor	Device Malfunction	7 states
17 Oct 2018	CLASS II	Verasense for Zimmer Biomet Persona CR C-D/3-9 Right recalled	Orthosensor	Device Malfunction	7 states
17 Oct 2018	CLASS II	Verasense for Zimmer Biomet Persona CR C-D/3-9 Left recalled	Orthosensor	Device Malfunction	7 states

More recalls from Orthosensor

All 8

Reported	Class	Recall	Company	Reason	Where
17 Oct 2018Device	CLASS II	Verasense for Zimmer Biomet Persona CR C-D/3-9 Left recalled	Orthosensor	Device Malfunction	7 states
17 Oct 2018Device	CLASS II	Verasense for Zimmer Biomet Persona CR C-D/3-9 Right recalled	Orthosensor	Device Malfunction	7 states
17 Oct 2018Device	CLASS II	Verasense for Zimmer Biomet Persona CR E-F/3-11 Right recalled	Orthosensor	Device Malfunction	7 states
17 Oct 2018Device	CLASS II	Verasense for Zimmer Biomet Persona CR G-H/7-12 Right recalled	Orthosensor	Device Malfunction	7 states
17 Oct 2018Device	CLASS II	Verasense for Zimmer Biomet Persona CR E-F/3-11 Left recalled	Orthosensor	Device Malfunction	7 states

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