- Recalling firm
- Medacta Usa Inc
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- REF/UDI/Lot: 04.01.10.0970/07630542768910/2585086, 04.01.10.0971/07630542768927/2585087, 04.01.10.0972/07630542768934/2585088, 04.01.10.0973/07630542768941/2585089, 04.01.10.0974/07630542768958/2585090, 04.01.10.0975/07630542768965/2585091, 04.01.10.0976/07630542768972/2585092, 04.01.10.0977/07630542768989/2585093, 04.01.10.0978/07630542768996/2585094, 04.01.10.0979/07630542769009/2585095
- Units affected
- 50
- Distribution pattern
- US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.
- Firm location
- Memphis, TN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2618-2026
- Recall initiated
- April 30, 2026
- FDA classification date
- June 29, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 98944
- Last updated on HTM Vibe
- July 23, 2026