Device Recall Optetrak

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

Orthopedic Devices

2

Yes

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

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***. ''

serial numbers: 0900529-0900532

Orthopedic Devices

2

Yes

Distributed to one hospital in New York.

Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13

Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.

Orthopedic Devices

2

Yes

USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.

OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. || There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. || The Optetrak Logic Total Knee System is 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.