Recall Z-2618-2026— Medacta Usa Inc

Name: FDA recall Z-2618-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Class II · Ongoing

Class II FDA medical device recall by Medacta Usa Inc, initiated 2026-04-30. It names one FDA 510(k) clearance: K250644. Product: 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: 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..

Recalling firm: Medacta Usa Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-04-30
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K250644 — MSS - Monobloc stemMedacta International S.A.·cleared 2026-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.