FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
- Recall number
- Z-0196-2007
- Recalling firm
- Exactech, Inc.
- Product
- Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
- Status
- Terminated
- Initiated
- 2006-08-31
- Posted
- 2006-11-21
- Terminated
- 2012-05-03
- Reason
- Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.
- Root cause
- Other
- Action
- The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine.
- Quantity
- 30
- Distribution
- International distribution only---- including countries of South America, Africa and Europe
- Lot, serial or model codes
- Serial numbers 0886395-0886424
- 510(k) numbers
- ["K010434"]
- 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