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The product is a Finned Tibial Tray. Product is labeled in… recallZ-1379-05 · Exactech, Inc. · initiated Jun 2, 2005

Terminated All recalls posted in August 2005

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

Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.

FDA root cause category: Other

What the company is doing

All consignees were notified by letter on 06/02/2005.

Recall details

Recall number
Z-1379-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 2, 2005
Posted by the FDA
Aug 18, 2005
Recalling firm
Exactech, Inc.
Quantity
41
Product code
JWH
FDA submissions
K932776
Distribution
Distributed to 15 Domestic Consignees 4 Foreign Distributors.

Product description

The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''.

Code information (models, lots, serial numbers)

Serial number range 0696020 - 0696061.

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