Medacta Usa Inc recalls

Hazard
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…

Details
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: US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.. Recall #Z-2618-2026, initiated 20260430. Voluntary: Firm initiated.

Products affected
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

Recall status
Ongoing