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Titan™ Total Shoulder System
Ascension Orthopedics, Inc. · Model MHH-0923-010-5022C · UDI-DI 10381780123484
1
510(k) clearances
23,453
Adverse events (33 deaths)
152
Recalls
216
Facilities
Description
The Titan Modular Total Shoulder Humeral Head has a concentric 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 |
|---|---|---|
| 2026-03-05 | 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 |
| 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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Get your free API keyRead the docsData 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.