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Terminated

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

FDA Recall Z-0603-2018 · Posted 2018-01-18

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeOLO
Date Initiated2017-07-11
Date Terminated2021-04-22
Product Quantity41 devices

Reason for Recall

Vix Bit may fracture during use.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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