Home › Device types › HSD
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
FDA product code HSD · Class 2 · Orthopedic
0
Registered devices
10,379
Adverse events
19
Recalls
71
510(k) clearances
Devices with this code
Comprehensive® Shoulder System — Biomet Orthopedics, LLCLINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KGFX V135 — FX Shoulder Solutions, Inc.AETOS Shoulder System — Smith & Nephew, Inc.AEQUALIS REVERSED — TORNIERAequalis™ Fx2 — TORNIERReUnion — Howmedica Osteonics Corp.Tornier Flex Shoulder System — TORNIERShoulder Innovations Humeral Stemless System — Shoulder Innovations, Inc.AETOS Shoulder System — Smith & Nephew, Inc.Bigliani/Flatow® — Zimmer, Inc.Trabecular Metal® — Zimmer, Inc.Anatomical Shoulder™ Domelock® — Zimmer GmbHLINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KGFX V135 Shoulder Prosthesis — FX SOLUTIONSBigliani / Flatow — Zimmer, Inc.Identity™ — Zimmer, Inc.FX V 135 stem — FX SOLUTIONSComprehensive® Shoulder System — Biomet Orthopedics, LLCAnatomical Shoulder™ Bigliani/Flatow® — Zimmer GmbHNEER — Smith & Nephew, Inc.Comprehensive® Shoulder System — Biomet Orthopedics, LLCINHANCE — DEPUY (IRELAND)Tornier HRS — TORNIER, INC.
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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