Food, drugs, devices › Exactech, Inc.
Device recall: Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Exactech, Inc. (Gainesville, FL) initiated this device recall on 11 Jul 2017; FDA lists 1 product record under event 78064, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 22 Apr 2021. Initiation: voluntary: firm initiated. Exactech, Inc. has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Exactech, Inc., Gainesville, FL.
Reason for recall
"Vix Bit may fracture during use."
Distribution
"Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0603-2018 | Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool | 41 devices | Class II | Terminated | 21 Feb 2018 |
Context
Other enforcement events for Exactech, Inc.
All 61 events for Exactech, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Vix Bit may fracture during use."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Apr 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.