FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Exactech Optetrak Logic CC 15mm Tibial Augment Screws
- Recall number
- Z-2704-2017
- Recalling firm
- Exactech, Inc.
- Product
- Exactech Optetrak Logic CC 15mm Tibial Augment Screws
- Status
- Terminated
- Initiated
- 2017-04-07
- Posted
- 2017-06-19
- Terminated
- 2020-08-04
- Reason
- Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
- Root cause
- Process control
- Action
- Consignees were initially contacted by phone on 04/07/2017. Consignees were sent a recall notice by mail, dated 04/13/2017. The notice requested that consignees immediately cease distribution/use of product, that the recall Extend the information to accounts in possession of the product Identify/quarantine any subject devices in your inventory Complete & return the attached Recall Inventory Response Form to Exactech within 5 business days at 2411 NW 66th Ct, Gainesville, FL 32653 or faxed to 352-337-3915. Questions from customers are to be directed to Kaya Davis at kaya@exac.com or 800-392-2832.
- Quantity
- 9 devices
- Distribution
- CA and NY.
- Lot, serial or model codes
- Catalog No. 02-012-50-9015; Serial #'s 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538.
- 510(k) numbers
- ["K150890"]
- 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