FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
- Recall number
- Z-0136-2018
- Recalling firm
- Exactech, Inc.
- Product
- Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
- Status
- Terminated
- Initiated
- 2017-09-19
- Posted
- not on file
- Terminated
- 2021-06-21
- Reason
- There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
- Root cause
- Labeling design
- Action
- The recalling firm issued a letter dated 9/19/2017 via email to their customers.
- Quantity
- 683 devices
- Distribution
- Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.
- Lot, serial or model codes
- All lot numbers
- 510(k) numbers
- ["K023186"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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