Recall Z-3019-2020 ยท PHX Shoulder Prosthesis, Reverse Configuration
Exactech, Inc.
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
| Date | Aug 24, 2020 |
| Status | Terminated |
| Reason | Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw. |
| Root cause | Labeling Change Control |
| Action | On 8/24/2020 the firm provided a letter to their consignees with the following instructions: In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of this product. " Extend this information to your accounts that may have this product in their possesrion. " Identify and quarantine any of the subject devices in your inventory (including loaer kits). " Complete and return the attached Recall Inventory Response Form to Exactech via email a recalls@exac.com. |
| Quantity | 125 devices |
| Distribution | Domestic Distribution: KS, CA, AR, NY, OH, IL, WI, AZ, LA, KY, VA, IN, TX, HI, MN, FL, TN, GA, ID, ME, CO, WA, SC. International Distribution: Austria, Australia, Germany, France, Spain, Italy, Japan, United Kingdom, Luxembourg, Netherlands, South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063569 | EQUINOXE REVERSE SHOULDER SYSTEM Exactech, Inc., Feb 23, 2007 |