Recall Z-2618-2026 ยท PHX Shoulder Prosthesis, Reverse Configuration
Medacta Usa Inc
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
| Date | Jun 29, 2026 (initiated Apr 30, 2026) |
| Status | Open, Classified |
| Reason | Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus. |
| Root cause | Device Design |
| Action | On 4/30/2026, field safety notices were emailed to customers who were asked to do the following: No pre-emptive interventions are recommended, however monitoring of the range of motion and stability should be evaluated during patient follow-up visits as per the standard of care. " Return all units of the lot numbers listed to firm. " Forward this notice to all people and organizations potentially affected. Firm Customer Service can be reached at 312-878-2381. |
| Quantity | 50 |
| Distribution | US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K250644 | MSS - Monobloc stem Medacta International S.A., Feb 3, 2026 |