—#160831

Product

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 product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K113309
Affected lot / code info: Catalog #: 314-13-03 Serial Range: 5013020 - 5013049

Why it was recalled

Potentially mislabeled.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2017-08-31
Posted by FDA: 2018-01-18
Terminated: 2019-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160831. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.