Recall Z-1258-2014— Zimmer, Inc.

Name: FDA recall Z-1258-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-25

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-02-25, terminated 2015-03-24. It names one FDA 510(k) clearance: K925242. Product: Apollo" Knee System: APOLLO PATELLA SZ0 28MM R. Reason: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-25
Terminated: 2015-03-24
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K925242 — APOLLO(TM) KNEE SYSTEMIntermedics Orthopedics·cleared 1993-06-04

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

Apollo" Knee System: APOLLO PATELLA SZ0 28MM R

Reason for recall

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

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