Home › Device types › HSD
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
FDA product code HSD · Class 2 · Orthopedic
8,149
Registered devices
10,195
Adverse events
19
Recalls
71
510(k) clearances
Devices with this code
SHOULDER INNOVATIONS TSA SYSTEM — Shoulder Innovations, Inc.GLOBAL UNITE — DEPUY (IRELAND)Equinoxe — Exactech, Inc.PROMOS — Smith & Nephew, Inc.Equinoxe — Exactech, Inc.Identity® Shoulder System — Zimmer, Inc.Equinoxe — Exactech, Inc.Tornier Perform Humeral System — TORNIER, INC.ACUMED — Acumed LLCTornier HRS Max — TORNIER, INC.Arthrex® — ARTHREX, INC.Humelock Reversed Shoulder — FX SOLUTIONSPRIMA — LIMACORPORATE SPAARROW Short Stem Humeral System — FOURNITURES HOSPITALIERES INDUSTRIEAGILON® XO trial cap inverse — implantcast GmbHSMR Shoulder — LIMACORPORATE SPATornier Perform Humeral System — TORNIER, INC.DELTA XTEND — DEPUY (IRELAND)PRIMA — LIMACORPORATE SPAAETOS Shoulder System — Smith & Nephew, Inc.Anatomical Shoulder# — Zimmer GmbHPERFORM™ HUMERAL SYSTEM — TORNIER, INC.Flex Shoulder System — TORNIERACUMED — Acumed LLC
Recent 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 w |
| 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 w |
| 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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