Titan™ Total Shoulder System
Ascension Orthopedics, Inc. · Model GLN092003000K · UDI-DI 10381780120155
Description
The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal bodies, humeral stems, and humeral heads in the TITAN™ Modular Total Shoulder System for total replacement Arthroplasty and provide stable fixation, proximal bone loading, and proper head placement. The glenoid component is intended for use of correction of humeral joint due to severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. The component is also used in repairing fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory as well as other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-11-09 | Exactech, Inc. | Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. |
| 2018-11-16 | Ascension Orthopedics, Inc | The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant). |
| 2018-06-04 | Fx Solutions | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. |
| 2018-06-04 | Fx Solutions | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. |
| 2017-12-08 | Zimmer Biomet, Inc. | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with inco |
| 2017-12-08 | Zimmer Biomet, Inc. | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with inco |
| 2017-08-31 | DePuy Orthopaedics, Inc. | The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. |
| 2015-08-14 | Limacorporate S.p.A | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. |
| 2014-11-24 | Arthrosurface, Inc. | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. |
| 2014-11-24 | Arthrosurface, Inc. | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. |
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