Exactech GPS Total Shoulder Application 3.2mm Vix Bit… recallZ-0603-2018 · Exactech, Inc. · initiated Jul 11, 2017
Class II Terminated All recalls posted in January 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Vix Bit may fracture during use.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0603-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 11, 2017
- Posted by the FDA
- Jan 18, 2018
- Recalling firm
- Exactech, Inc.
- Quantity
- 41 devices
- Product code
- OLO
- FDA submissions
- K162567
- Distribution
- Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
Product description
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Code information (models, lots, serial numbers)
Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001
Other devices under the same FDA submission
7 devices cleared under K162567 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- GPS 531-07-05Exactech, Inc. · System, image processing, radiological1 recall2 reports
- GPS 531-25-00Exactech, Inc. · System, image processing, radiological2 reports
- GPS 531-01-03Exactech, Inc. · System, image processing, radiological2 reports
- GPS 531-20-00Exactech, Inc. · System, image processing, radiological1 report
- GPS 531-01-04Exactech, Inc. · Orthopedic stereotaxic instrument1 report
- Equinoxe 531-55-26Exactech, Inc. · System, Image Processing, Radiological1 report
- Equinoxe 531-55-64Exactech, Inc. · System, Image Processing, Radiological1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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