NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4, sterile, R

FDA device recall Z-2411-2010 · posted 2010-09-13 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device.

Action taken

The firm, Zimmer, Inc., sent an "URGENT DEVICE CORRECTION" letter dated April 26, 2010, to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to destroy or disregard all previous versions of the surgical technique, review the attached revised surgical technique to familiarize yourself with the modifications and warnings, and complete and return the Health Care Professional Dcoumentation Form via fax to Zimmer, Inc. at (574) 372-4265. (Note: Zimmer made a modification to the surgical technique and instructions for use. They added a warning to fully cement and pressurize the anterior and posterior surfaces of the tibial component, and to strongly recommend the use of a drop down stem extension. This change was completed and approved on April 23, 2010.) For questions please contact Zimmer at 1-877-946-2761.

Root cause

Other

Status

Terminated

Product code

JWH

Quantity affected

68,384 all products

Distribution

Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerla

Date initiated

2010-04-26

Date posted

2010-09-13

Date terminated

2011-03-28

Location

Warsaw, IN

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