Z-0603-2018Class II

Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

Name: Z-0603-2018 Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Creator: Exactech, Inc.
Published: 2017-07-11
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2017-07-11 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool on 2017-07-11. FDA classified it as Class II and gives the reason as "Vix Bit may fracture during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0603-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-11
Posted: 2018-01-18
Terminated: 2021-04-22
Recalling firm: Exactech, Inc.
Product: Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Vix Bit may fracture during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 41 devices
Distribution: Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
Product codes and lots: Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0603-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0603-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code OLO

K162567Class IIExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho / cleared 2017-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)