Recall Z-1259-2014— Zimmer, Inc.

Name: FDA recall Z-1259-2014
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: K934381. Product: Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO. 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

K934381 — APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERTIntermedics Orthopedics·cleared 1995-02-08

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 Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO

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.