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OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT… recallZ-2234-2012 · Exactech, Inc. · initiated Oct 17, 2011

Class II Terminated All recalls posted in August 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 recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.

FDA root cause category: Device Design

What the company is doing

The firm, Exactech, Inc., sent a "IMPORTANT PRODUCT RECALL NOTICE" date October 17, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately cease distribution or use of these products; extend this information to their accounts that may have possession of this product; verify if they have any of the subject Logic size 2.5 Proximal Tibial Spacer products, complete and return the attached PRODUCT RECALL FAX NOTICE form within five (5) working days via fax to: 352-337-3915, and to contact the firm inventory representative to confirm quantities at the location. For questions regarding inventory restocking, please call 1-800-392-2832.

Recall details

Recall number
Z-2234-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 17, 2011
Posted by the FDA
Aug 21, 2012
Recalling firm
Exactech, Inc.
Quantity
70
Product code
JWH
FDA submissions
K071738
Distribution
Nationwide distribution: USA including states of: AL, AZ, CO, FL, GA, IL, LA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TN, VA, and WA.

Product description

OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. 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. The Optetrak Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

Code information (models, lots, serial numbers)

Catalog Number: 02-012-42-2508.

Other devices under the same FDA submission

3 devices cleared under K071738 — 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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