Home › Device types › KWT
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
FDA product code KWT · Class 2 · Orthopedic
7,460
Registered devices
5,740
Adverse events
31
Recalls
72
510(k) clearances
Devices with this code
Comprehensive® Shoulder System — Biomet Orthopedics, LLCFX V135 — FX Shoulder Solutions, Inc.AETOS Shoulder System — Smith & Nephew, Inc.JARVIS Glenoid Rerverse Shoulder Prosthesis — FOURNITURES HOSPITALIERES INDUSTRIETornier Flex Shoulder System — TORNIEROSS™ Orthopedic Salvage System — Biomet Orthopedics, LLCShoulder Innovations Humeral Stemless System — Shoulder Innovations, Inc.AETOS Shoulder System — Smith & Nephew, Inc.JARVIS Glenoid Rerverse Shoulder Prosthesis — FOURNITURES HOSPITALIERES INDUSTRIEBigliani/Flatow® — Zimmer, Inc.Trabecular Metal® — Zimmer, Inc.Anatomical Shoulder™ Domelock® — Zimmer GmbHFX V135 Shoulder Prosthesis — FX SOLUTIONSBigliani / Flatow — Zimmer, Inc.Identity™ — Zimmer, Inc.FX V 135 stem — FX SOLUTIONSEquinoxe — Exactech, Inc.OSS™ Orthopedic Salvage System — Biomet Orthopedics, LLCComprehensive® Shoulder System — Biomet Orthopedics, LLCAnatomical Shoulder™ Bigliani/Flatow® — Zimmer GmbHComprehensive® Shoulder System — Biomet Orthopedics, LLCINHANCE — DEPUY (IRELAND)Equinoxe — Exactech, Inc.Comprehensive® Shoulder System — Biomet Orthopedics, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-21 | Exactech, Inc. | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2018-08-21 | Exactech, Inc. | The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended. |
| 2018-02-28 | Biomet, Inc. | During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismat |
| 2017-06-05 | Zimmer Biomet, Inc. | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the inte |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the su |
| 2016-10-25 | Exactech, Inc. | Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. |
| 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. |
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