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Glenoid IRI Leg (16mm)

CUSTOM ORTHOPAEDIC SOLUTIONS, INC. · Model L · UDI-DI 00811813020105

PHX KWS Prescription

510(k) clearances

12,769

Adverse events (11 deaths)

Recalls

191

Facilities

Description

The Glenoid IRI Leg (16mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (16mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).

Recalls

Date	Firm	Reason
2026-06-30	restor3d Inc.	Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
2026-05-20	Zimmer, Inc.	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
2026-05-20	Zimmer, Inc.	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
2026-05-20	Zimmer, Inc.	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
2026-05-20	Zimmer, Inc.	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
2026-05-20	Zimmer, Inc.	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
2026-04-30	Medacta Usa Inc	Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are posit
2026-01-15	Encore Medical, LP	Knee and Humeral socket implants contain incorrect labeling.
2025-09-05	Exactech, Inc.	Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
2025-09-05	Exactech, Inc.	Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.