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Product is labeled in part: "***OPTETRAK***TIBIAL… recallZ-2070-2012 · Exactech, Inc. · initiated Sep 23, 2011

Class II Terminated All recalls posted in July 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T. Both trays have the potential to be mislabeled.

FDA root cause category: Labeling mix-ups

What the company is doing

Exactech, Inc. sent an "IMPORTANT MARKET WITHDRAWAL NOTICE" on September 23, 2011, to all affected customers. The customers were instructed to: 1. Immediately cease distribution or use of the products. 2. Extend the information to accounts that has possession of the products. 3. Verify if they have any of the affected products listed. 4. Fax back the attached form. Customers were instructed to contact Exactech inventory representative to confirm quantities at their location. For questions regarding any inventory restocking, the customers were directed to contact Kaya Davis 1-800-392-2832.

Recall details

Recall number
Z-2070-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 23, 2011
Posted by the FDA
Jul 24, 2012
Recalling firm
Exactech, Inc.
Quantity
16
Product code
JWH
FDA submissions
K933610
Distribution
Worldwide Distribution-USA-including the states of CA, MA, OH, and OK, and the countries of Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain.

Product description

Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the Optetrak Comprehensive Knee System is indicated for cemented use only.

Code information (models, lots, serial numbers)

Serial number range 2067442 - 2067457.

Other devices under the same FDA submission

71 devices cleared under K933610 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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