Z-1610-2014Class II

PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee...

Name: Z-1610-2014 PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee...
Creator: Ortho Development Corporation
Published: 2014-04-01
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2014-04-01 / Terminated / root cause: manufacturing process

FDA source

Ortho Development Corporation began a recall of PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty... on 2014-04-01. FDA classified it as Class II and gives the reason as "A femoral component containing pegs was found in a box for the pegless version". 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-1610-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-01
Posted: 2014-05-13
Terminated: 2014-07-14
Recalling firm: Ortho Development Corp.
Product: PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: A femoral component containing pegs was found in a box for the pegless version.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.
Quantity in commerce: 5
Distribution: US Nationwide Distribution in the states of NV, and AZ.
Product codes and lots: Lot No. A131876

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1610-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1610-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-12

Product code JWH

K994370Class IIOrtho Development Balanced Knee SystemOrtho Development Corp. / cleared 2000-03-24

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)