FDA Medical Device Recalls (openFDA)
Exactech, Inc.: The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''.
- Recall number
- Z-1379-05
- Recalling firm
- Exactech, Inc.
- Product
- The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''.
- Status
- Terminated
- Initiated
- 2005-06-02
- Posted
- 2005-08-18
- Terminated
- 2008-10-24
- Reason
- Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.
- Root cause
- Other
- Action
- All consignees were notified by letter on 06/02/2005.
- Quantity
- 41
- Distribution
- Distributed to 15 Domestic Consignees 4 Foreign Distributors.
- Lot, serial or model codes
- Serial number range 0696020 - 0696061.
- 510(k) numbers
- ["K932776"]
- 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