Recalls / —

—#158599

Product

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

FDA product code

OLO — Orthopedic Stereotaxic Instrument

Device class

Class 2

Medical specialty

Neurology

510(k) numbers

K162567

Affected lot / code info

Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001

Why it was recalled

Vix Bit may fracture during use.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Exactech, Inc.

Address

2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern

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

Timeline

Recall initiated

2017-07-11

Posted by FDA

2018-01-18

Terminated

2021-04-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #158599. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.