Recall Z-1610-2014— Ortho Development Corporation

Name: FDA recall Z-1610-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-01

Class II · Terminated

Class II FDA medical device recall by Ortho Development Corporation, initiated 2014-04-01, terminated 2014-07-14. It names one FDA 510(k) clearance: K994370. 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.. Reason: A femoral component containing pegs was found in a box for the pegless version..

Recalling firm: Ortho Development Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-04-01
Terminated: 2014-07-14
Firm location: Draper, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K994370 — ORTHO DEVELOPMENT BALANCED KNEE SYSTEMOrtho Development Corp.·cleared 2000-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

A femoral component containing pegs was found in a box for the pegless version.

Data sourced from openFDA. This site is unofficial and independent of the FDA.