Z-1340-2016Class II

Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile...

Name: Z-1340-2016 Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile...
Creator: Zimmer Manufacturing B.V.
Published: 2016-03-17
License: https://open.fda.gov/license/

Zimmer Manufacturing B.V. / initiated 2016-03-17 / Terminated / root cause: manufacturing process

FDA source

Zimmer Manufacturing B.V. began a recall of Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF... on 2016-03-17. FDA classified it as Class II and gives the reason as "The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1340-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-17
Posted: 2016-04-06
Terminated: 2017-03-14
Recalling firm: Zimmer Manufacturing B.V.
Product: Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Distributors, Sales Representatives, Operation Managers, and Hospital Risk Managers will be provided with an "Urgent Medical Device Recall-Lot Specific" letter.
Quantity in commerce: TBD
Distribution: Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
Product codes and lots: lot 62646580

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1340-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1340-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-06
Z-1341-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-06

Product code JWH

K113369Class IIZimmer Persona Knee SystemZimmer, Inc. / cleared 2012-03-27

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)