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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
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 23, 2026 at 11:04 PM UTC.
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