FDAClass II · Medical device · Recalled July 8, 2026

Short Monobloc Stem Broaches recall — Medacta Usa Inc

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 region of the proximal humerus.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2618-2026
Brand: Medacta Usa
Classification: Class II
Units affected: 50
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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

Affected products

Short Monobloc Stem Broaches

Companies & origin

Recalling firm location: Memphis, TN, United States
Firm address: 3973 Delp St, N/A, 38118-6110

Identifying details (verbatim from the notice)

Product codes / lots: 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
Distribution: US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.
Firm notified the public via: N/A
FDA event ID: 98944
Recall initiated: April 30, 2026
FDA classified: June 29, 2026
FDA report date: July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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