Exactech GPS Total Shoulder Vix Bit Recall: Fracture Risk During Use
Exactech recalls 3.2mm Vix Bit orthopedic surgical tools due to fracture risk during use. Affected items have specific catalog and lot numbers. Consumers should contact Exactech for details.
Use caution until it’s fixed
Vix Bit may fracture during use.
Contact the company
What happened, in plain English
Exactech is recalling its GPS Total Shoulder Application 3.2mm Vix Bit orthopedic surgical tools because they may fracture during use. This could lead to complications for patients during surgery. Read more at govinfonow.com/recall/73442-exactech-gps-total-shoulder-vix-bit-recall-fracture-risk-during.
Source Summary by GovInfoNow · govinfonow.com/recall/73442-exactech-gps-total-shoulder-vix-bit-recall-fracture-risk-during · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0603-2018
Cite this page
“Exactech GPS Total Shoulder Vix Bit Recall: Fracture Risk During Use.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73442-exactech-gps-total-shoulder-vix-bit-recall-fracture-risk-during. Based on FDA recall #Z-0603-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0603-2018%22&limit=1).
Why it’s dangerous
The Vix Bit may fracture during surgical procedures, potentially causing injury to the patient or damaging surgical equipment. Fractures can occur under normal use conditions, leading to complications during surgery.
Who’s affected
Orthopedic surgeons and surgical teams using the Exactech GPS Total Shoulder Application 3.2mm Vix Bit during procedures are most at risk. Patients undergoing surgery with this tool may face complications if the bit fractures.
How to tell if you have this one
Check for catalog number 531-15-08 and lot numbers 75296003, 80129003, or 81327001 on the tool's packaging or label. This orthopedic surgical tool was sold for use in shoulder procedures.
- Brand
Exactech- Category
Medical device
What to do — step by step
Check Product Details
Verify the catalog number (531-15-08) and lot numbers (75296003, 80129003, 81327001) on the tool's packaging or label.
Where it went and when
Where it was distributed
Distributed in California and Florida, and outside the U.S.
FDA distribution: “Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0603-2018 (July 11, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0603-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.