FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
- Recall number
- Z-0603-2018
- Recalling firm
- Exactech, Inc.
- Product
- Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
- Status
- Terminated
- Initiated
- 2017-07-11
- Posted
- 2018-01-18
- Terminated
- 2021-04-22
- Reason
- Vix Bit may fracture during use.
- Root cause
- Nonconforming Material/Component
- Action
- Customers were notified on approximately 07/11/2017. Instructions included cease distribution of the affected product, notify customers if further distributed, identify and quarantine any product in inventory and complete and return the Recall Inventory Response Form. For further questions, please call (800) 392-2832.
- Quantity
- 41 devices
- Distribution
- Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
- Lot, serial or model codes
- Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001
- 510(k) numbers
- ["K162567"]
- PMA numbers
- not on file
- Product code
- OLO
- 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