Z-2618-2026 Class II Ongoing
FDA device recall Z-2618-2026 was initiated by Medacta Usa Inc on April 30, 2026 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 50.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- April 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50
Product Description
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
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.
Distribution Pattern
US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.
Code Information
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