Recall Z-2091-2012— Zimmer Inc.

Name: FDA recall Z-2091-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-30

Class II · Terminated

Class II FDA medical device recall by Zimmer Inc., initiated 2012-04-30, terminated 2014-06-04. It names one FDA 510(k) clearance: K031061. Product: Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.. Reason: The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall.

Recalling firm: Zimmer Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-04-30
Terminated: 2014-06-04
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K031061 — NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTSZimmer, Inc.·cleared 2003-10-09

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

Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

Reason for recall

The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall

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