FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
- Recall number
- Z-0347-05
- Recalling firm
- Exactech, Inc.
- Product
- Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
- Status
- Terminated
- Initiated
- 2004-11-11
- Posted
- 2004-12-23
- Terminated
- 2012-05-03
- Reason
- Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information.
- Root cause
- Other
- 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.
- Quantity
- 21 implants
- Distribution
- Distributed to New Jersey, Florida, Minnesota, New York, Maryland, Texas and the United Kingdom
- Lot, serial or model codes
- Serial numbers 0638851-0638871
- 510(k) numbers
- ["K933610"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28