Z-1224-2018Class II

PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain...

Name: Z-1224-2018 PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain...
Creator: Zimmer Biomet, Inc.
Published: 2017-12-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-12-12 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis... on 2017-12-12. FDA classified it as Class II and gives the reason as "A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1224-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-12
Posted: 2018-03-27
Terminated: 2019-04-09
Recalling firm: Zimmer GmbH
Product: PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Product code: JHW U.V. Method, Cpk Isoenzymes
Reason for recall: A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
FDA root cause: Under Investigation by firm
Action: On December 12, 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers will the following guidance: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. Questions or concerns can be directed to 1-574-371-3071.
Quantity in commerce: 3 units
Distribution: Non-USA Customer
Product codes and lots: Item# 42-5320-067-02 Lot # 63236047

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1224-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1224-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code JHW

K122765Class IIPersona Natural Tibia BaseplatesZimmer, Inc. / cleared 2012-11-09

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)