Home › Ascension Orthopedics, Inc. › Titan™ Reverse Shoulder System
Titan™ Reverse Shoulder System
Ascension Orthopedics, Inc. · Model BBS096021LRG · UDI-DI 10381780121541
KWS
Prescription
1
510(k) clearances
23,762
Adverse events (33 deaths)
153
Recalls
218
Facilities
Description
The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation.
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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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.