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OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match… recallZ-2310-2012 · Exactech, Inc. · initiated Aug 19, 2011

Class II Terminated All recalls posted in September 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. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.

FDA root cause category: Device Design

What the company is doing

Exactech, Inc., sent an "IMPORTANT PRODUCT MARKET WITHDRAWAL NOTICE" letter dated August 19, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1. Immediately cease distribution or use of the products. 2. Extend the information to accounts that are in possession of the products. 3. Verify if they had any of the affected products on the list. 4. Fax back the attached form. In addition, they were instructed to contact the Exactech inventory representative to confirm quantities at their location. If you have any questions regarding inventory restocking issue, please call -800-392-2832.

Recall details

Recall number
Z-2310-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 19, 2011
Posted by the FDA
Sep 4, 2012
Recalling firm
Exactech, Inc.
Quantity
193
Product code
JWH
FDA submissions
K093360
Distribution
USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.

Product description

OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak Logic Total Knee System is 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.

Code information (models, lots, serial numbers)

Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.

Other devices under the same FDA submission

29 devices cleared under K093360 — 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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