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Titan™

Ascension Orthopedics, Inc. · Model TSS3IMP · UDI-DI 10381780237495

HSD KWS Prescription

510(k) clearances

10,267

Adverse events (34 deaths)

Recalls

216

Facilities

Description

The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. The humeral tray 3 includes keeled and pegged glenoid trials to evaluate the size and fit of the implant. Glenoid sizers are included to visualize the implant size and anticipate the amount of bone resections. Various instruments are provided to assist with the procedure.

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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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.