—#43488

Product

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 product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K932776
Affected lot / code info: Catalogue number 200-04-45; Serial number range 0730621-07306351; Lot number 452500.

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.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2005-12-19
Posted by FDA: 2006-06-02
Terminated: 2012-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43488. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.