Exactech, Inc. Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
Serial numbers 0638851-0638871
Products Sold
Serial numbers 0638851-0638871
Exactech, Inc. is recalling Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi- due to Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information.
Recommended Action
Per FDA guidance
A recall letter was sent to all customers on November, 2, 2004 recalling all 21 units. These implants will be quarantined and then returned to the supplier for disposal when all 21 implants are received.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, MD, MN, NJ, NY, TX
Page updated: Jan 10, 2026