Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
FDA Recall Z-0347-05 · Posted 2004-12-23
Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2004-11-11
Date Terminated2012-05-03
Product Quantity21 implants
Reason for Recall
Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Distributed to New Jersey, Florida, Minnesota, New York, Maryland, Texas and the United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.