Recall Z-0414-2018 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Exactech, Inc.
Equinoxe Cage, Glenoid, Alpha, Small 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.
| Date | Jan 18, 2018 (initiated Aug 31, 2017) |
| Status | Terminated |
| Reason | Potentially mislabeled. |
| Root cause | Under Investigation by 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. |
| Quantity | 30 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113309 | EXACTECH EQUINOXE CAGE GLENOIDS Exactech, Inc., Dec 8, 2011 |