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Titan™ Total Shoulder System

Ascension Orthopedics, Inc. · Model M9200104620E · UDI-DI 10381780120360

KWS HSD Prescription

510(k) clearances

23,453

Adverse events (33 deaths)

153

Recalls

216

Facilities

Description

The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the polyethylene cemented glenoid bone. It is intended for optimal osteotomy coverage and soft tissue balancing.

Recalls

Date	Firm	Reason
2026-07-30	Howmedica Osteonics Corp.	Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o
2026-03-05	Tornier, Inc	Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max s
2026-01-15	Encore Medical, LP	Knee and Humeral socket implants contain incorrect labeling.
2025-12-19	Tornier, Inc	A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a m
2025-07-18	Encore Medical, LP	Their is a potential that the reamer may kick or bind up during or immediately prior to use.
2025-07-18	Encore Medical, LP	Their is a potential that the reamer may kick or bind up during or immediately prior to use.
2025-07-18	Encore Medical, LP	Their is a potential that the reamer may kick or bind up during or immediately prior to use.
2024-03-06	Exactech, Inc.	The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags
2024-03-06	Exactech, Inc.	The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags
2024-03-06	Exactech, Inc.	The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags

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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.