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Template
FDA product code HWT · Class 1 · Orthopedic
43,593
Registered devices
16,914
Adverse events
85
Recalls
10
510(k) clearances
Devices with this code
Surgical Instrument — Jeil Medical CorporationMAXIM PROVISIONAL TIBIAL BEARING — Biomet Orthopedics, LLCEcho® Bi-Metric® Microplasty® Hip Stem — Biomet Orthopedics, LLCSurgical Instrument — Jeil Medical CorporationEVOLUTION® — Microport Orthopedics Inc.Irix-C Cervical Integrated Fusion System — Xtant Medical Holdings, Inc.IMPLANT PARTNERS™ — Microport Orthopedics Inc.EVOLUTION® — Microport Orthopedics Inc.LEOPARD — DEPUY SPINE, LLCEvolution Revision CCK System — Microport Orthopedics Inc.NA — Exactech, Inc.SIGMA LCS — DEPUY ORTHOPAEDICS, INC.SIGMA — DEPUY ORTHOPAEDICS, INC.ATTUNE — DEPUY (IRELAND)NA — DEPUY SPINE, LLCN/A — MEDTRONIC SOFAMOR DANEK, INC.n/a — MEDTRONIC SOFAMOR DANEK, INC.PROFEMUR® — Microport Orthopedics Inc.ACS® — implantcast GmbHINTERSEAL® — Microport Orthopedics Inc.Integra® XT — Ascension Orthopedics, Inc.N/A — MEDTRONIC SOFAMOR DANEK, INC.N/A — MEDTRONIC SOFAMOR DANEK, INC.4WEB Medical — 4web Medical
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-27 | LINK BIO CORP | The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizi |
| 2022-07-13 | Materialise USA LLC | MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK |
| 2022-06-29 | DePuy Orthopaedics, Inc. | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTU |
| 2017-12-20 | Integra LifeSciences Corp. | Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral |
| 2017-08-10 | Aesculap Implant Systems LLC | The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation o |
| 2017-04-11 | Biomet Microfixation, LLC | Part of the number on the tray lid differ from the part number on the base. |
| 2015-06-24 | Encore Medical, Lp | The markings on the distal face of the instruments are mis-oriented by 180. This includes Anterior and Posterior, which the surgeon uses to correctly place the |
| 2015-06-03 | Biomet, Inc. | Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link. |
| 2014-09-24 | Biomet, Inc. | An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial. |
| 2014-03-28 | DePuy Orthopaedics, Inc. | Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possib |
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