Home › Device types › KWT
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
FDA product code KWT · Class 2 · Orthopedic
7,012
Registered devices
5,649
Adverse events
31
Recalls
71
510(k) clearances
Devices with this code
SHOULDER INNOVATIONS TSA SYSTEM — Shoulder Innovations, Inc.Equinoxe — Exactech, Inc.Identity® Shoulder System — Zimmer, Inc.Equinoxe — Exactech, Inc.Signature ONE — Orthosoft IncTornier Perform Humeral System — TORNIER, INC.Tornier HRS Max — TORNIER, INC.PRIMA — LIMACORPORATE SPASMR Shoulder — LIMACORPORATE SPAPRIMA — LIMACORPORATE SPAAETOS Shoulder System — Smith & Nephew, Inc.Comprehensive — Biomet Orthopedics, LLCBio-Modular® Shoulder System — Biomet Orthopedics, LLCCSR Shoulder System — CATALYST ORTHOSCIENCE INC.Bigliani/Flatow® — Zimmer, Inc.COMPRESS DEVICE — Biomet Orthopedics, LLCBio-Modular® Shoulder System — Biomet Orthopedics, LLCShoulder Innovations InSet Slap Hammer Weight — Shoulder Innovations, Inc.JARVIS Glenoid Rerverse Shoulder Prosthesis — FOURNITURES HOSPITALIERES INDUSTRIEHandle baseplate — FOURNITURES HOSPITALIERES INDUSTRIETrabecular Metal® — Zimmer, Inc.COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, LLCSMR Shoulder — LIMACORPORATE SPACOMPREHENSIVE 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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