Z-0082-2019Class II

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L

Name: Z-0082-2019 OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L
Creator: Orthosensor, Inc.
Published: 2018-07-12
License: https://open.fda.gov/license/

Orthosensor, Inc. / initiated 2018-07-12 / Terminated

FDA source

Orthosensor, Inc. began a recall of OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L on 2018-07-12. FDA classified it as Class II and gives the reason as "Some sensors were reported to have fluid inside the posterior lateral corner post-surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0082-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-12
Posted: 2018-10-05
Terminated: 2019-06-27
Recalling firm: Orthosensor, Inc.
Product: OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Product code: ONN Intraoperative Orthopedic Joint Assessment Aid
Reason for recall: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
FDA root cause: Under Investigation by firm
Action: Letters dated 7/12/2018 were either delivered by the sales representatives or issued via email to their consignees on 7/13/2018 explaining the reason for recall and requesting return of the devices, if still available, for replacement. The firm expanded the recall via letter dated 8/29/2018 for delivery by sales representatives or via sales representative email on 8/30/2018.
Quantity in commerce: 41 devices
Distribution: Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
Product codes and lots: Lot numbers 20568, 20575, 20581, 20584, 20621, 20623, and 20628, UDI 00816818021430.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0082-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0082-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05
Z-0083-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05
Z-0084-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05
Z-0085-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05
Z-0086-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05
Z-0087-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05

Product code ONN

K180459Class IIVERASENSE for Zimmer Biomet PersonaOrthosensor, Inc. / cleared 2018-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)