Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
This recall has been terminated (originally issued December 23, 2004).
- Company
- Exactech, Inc.
- Recall Initiated
- November 11, 2004
- Posted
- December 23, 2004
- Terminated
- May 3, 2012
- Recall Number
- Z-0347-05
- Quantity
- 21 implants
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information.
Distribution
Distributed to New Jersey, Florida, Minnesota, New York, Maryland, Texas and the United Kingdom
Lot / Code Info
Serial numbers 0638851-0638871
Root Cause
Other
Action Taken
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.
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