Recall Z-1615-2020 ยท PHX Shoulder Prosthesis, Reverse Configuration
Biomet, Inc.
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589
| Date | Feb 25, 2020 |
| Status | Terminated |
| Reason | Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters. |
| Root cause | Packaging process control |
| Action | Zimmer Biomet issued notification letter on 2/25/20 via email to the International consignees states reason for recall, health risk and action to take: Hospital Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 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 | 21 units |
| Distribution | International distribution - country of Netherland.s |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120121 | COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE Biomet, Inc., Feb 16, 2012 |