Recall Z-2531-2026 ยท PHX Shoulder Prosthesis, Reverse Configuration
Zimmer, Inc.
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
| Date | Jun 23, 2026 (initiated May 20, 2026) |
| Status | Open, Classified |
| Reason | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL CORRECTION notification letter dated 5/26/26 was sent to customers. Distributor Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com. 3. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeon |
| Quantity | 13 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241043 | Augment Off-Axis Instrument System Fix Surgical, May 15, 2024 |