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Terminated

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***. ''

FDA Recall Z-0927-06 · Posted 2006-06-02

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-12-19
Date Terminated2012-06-29
Product Quantity14 implants from manufactured lot

Reason for Recall

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.

Firm Action

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

Root Cause

Other

Distribution Pattern

Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932776CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTSExactech, Inc. · 1994-10-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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