Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
FDA Recall Z-0415-2018 · Posted 2018-01-18
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeKWS
Date Initiated2017-08-31
Date Terminated2019-08-06
Product Quantity30
Reason for Recall
Potentially mislabeled.
Firm Action
Consignees were sent a Recall Notice dated 8/31/2017 by mail informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions please call (800) 392-2832.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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