Recall Z-0958-2019 · PHX Shoulder Prosthesis, Reverse Configuration
Exactech, Inc.
Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment. The Equinoxe Preserve Stems are additionally indica
| Date | Dec 5, 2018 |
| Status | Terminated |
| Reason | Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended . |
| Root cause | Packaging |
| Action | On about 12/05/2018, Exactech notified customers via "URGENT MEDICAL DEVICE RECALL" notification sent through email. Instructions included to immediately cease distribution or use of affected products, provide the recall information to customers if further distributed, identify and quarantine any affected devices in inventory, complete and return the Recall Acknowledgement Form, and make arrangements to return affected devices to Exactech. |
| Quantity | 40 devices |
| Distribution | US Nationwide distribution in the states of AL,FL, IA, LA, MD, OH, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162726 | Exactech® Equinoxe® Preserve Stem Exactech, Inc., Feb 1, 2017 |