Recall Z-1750-2020 ยท PHX Shoulder Prosthesis, Reverse Configuration
Biomet, Inc.
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
| Date | Mar 13, 2020 |
| Status | Terminated |
| Reason | There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. |
| Root cause | Under Investigation by firm |
| Action | URGENT MEDICAL DEVICE RECALL notification letters dated 3/13/20 were sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment |
| Quantity | 125 |
| Distribution | Worldwide distribution - US Nationwide distribution including the states of AL, CO, KS, MA, MD, MI, MO, NH, NJ, and PA. The countries of Australia, Canada, India, and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080642 | COMPREHENSIVE REVERSE SHOULDER Biomet, Inc., Jul 9, 2008 |