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SMR System

LIMACORPORATE SPA · Model 1322.09.444 · UDI-DI 08033390274159

HSDKWT Prescription
1
510(k) clearances
10,195
Adverse events (34 deaths)
19
Recalls
216
Facilities

Description

SMR System - Humeral Head Dia. 44 mm H. 13 mm Eccentrical 4mm

Recalls

DateFirmReason
2020-11-09Exactech, Inc.Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
2018-11-16Ascension Orthopedics, IncThe product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
2018-06-04Fx SolutionsBreach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
2018-06-04Fx SolutionsBreach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
2017-12-08Zimmer 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
2017-12-08Zimmer 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
2017-08-31DePuy Orthopaedics, Inc.The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
2015-08-14Limacorporate S.p.AThe dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
2014-11-24Arthrosurface, Inc.Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
2014-11-24Arthrosurface, 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.