Skip to content

Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T.… recallZ-0927-06 · Exactech, Inc. · initiated Dec 19, 2005

Terminated All recalls posted in June 2006

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

An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.

FDA root cause category: Other

What the company is doing

Each consignee contacted by mail 12/19/2005, and asked to return the product to Exactech. The returned product will be quarantined and evaluated.

Recall details

Recall number
Z-0927-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 19, 2005
Posted by the FDA
Jun 2, 2006
Recalling firm
Exactech, Inc.
Quantity
14 implants from manufactured lot
Product code
JWH
FDA submissions
K932776
Distribution
Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece.

Product description

Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesville, FL 32653***. ''

Code information (models, lots, serial numbers)

Catalogue number 200-04-45; Serial number range 0730621-07306351; Lot number 452500.

Other devices under the same FDA submission

44 devices cleared under K932776 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page