Recall Z-1260-2014— Zimmer, Inc.

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-02-25, terminated 2015-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS SZ4/11MM APOLL PS TIB INS SZ4/13MM APOLL PS TIB INS SZ4/16MM APOLL PS TIB INS SZ4/19MM APOLL PS TIB INS SZ4/22MM APOLL PS TIB INS SZ5/9MM APOLLO PS TIB INS SZ5/19MM APOLL. 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

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