Recalls / —

—#86898

Product

Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. The product is used as an implant for knee replacement.

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K072160

Affected lot / code info

All lots. Lots 00111134, 60747593, 60747594, 60752676, 60752677, 60760248, 60768076, 60821507, 60824004, 60830411, 60830412, 60845351, 60850604, 60852670, 60852671, 60860895, 60866613, 60872311, 60879050, 60892605, 60900745, 60907449, 60917234, 60922494, 60938889, 60938890, 60947027, 60947028, 60963035, 60963036, 60963037, 60963039, 60983254, 61015851, 61028168, 61033723, 61033724, 61068387, 61068388, 61068389, 61074754, 61074755, 61084771, 61096604, 61116246, 61116247, 61137056, 61143427, 61149041, 61157940, 61173295, 61193516, 61193520, 61198179, 61204038, 61215644, 61225562, 61235612, 61240323, 61248321, 61259184, 61263170, 61272449, 61285508, 61298201, 61306497, 61280371, 61315873, 61319581 and 61329266.

Why it was recalled

The titanium portion of the implant may separate from the trabecular metal material.

Root cause (FDA determination)

Other

Action the firm took

On December 1, 2009, an e-mail was sent to consignees for lot 60866613 to quarantine and return the product. On December 2, 2009 an e-mail was sent to U.S. distributors, and on December 3, 2009 and e-mail was sent to international distributors, instructing them to suspend usage and return all lots of size 8 trays. On December 9, 2009, a recall letter was sent to U.S. user accounts who received the products directly from Zimmer, U.S. distributors and Zimmer's U.S. sales force informing them of the recall. Direct questions about this recall to Zimmer, Inc. by calling 1-800-613-6131.

Recalling firm

Firm

Zimmer Inc.

Address

345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern

Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.

Timeline

Recall initiated

2009-11-16

Posted by FDA

2010-03-10

Terminated

2011-03-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #86898. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.