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FDA product code HWT · Class 1 · Orthopedic
0
Registered devices
17,203
Adverse events
85
Recalls
10
510(k) clearances
Devices with this code
Tranquil-L™ — NEXUS SPINE, L.L.C.AXIOM® — Microport Orthopedics Inc.IQ — Aesculap AGA.L.P.S.® — Biomet Orthopedics, LLCNA — Synthes GmbHEvolution Revision CCK System — Microport Orthopedics Inc.Equinoxe — Exactech, Inc.Equinoxe — Exactech, Inc.PLIF — DEPUY SPINE, LLCLUMBAR I/F CAGE — DEPUY SPINE, LLCAranax Anterior Cervical Plating System — Xtant Medical Holdings, Inc.Lordotic Trial Sizer with Stop 18x14, H10mm — Spineup, Inc.Alamo P — ALLIANCE PARTNERS LLCEXCIA — Aesculap AGIntervertebral Body Fusion Device — PRECISION SPINE, INC.Alliance Humeral Bearings — Zimmer, Inc.NA — DEPUY SPINE, LLCUni — Smith & Nephew, Inc.PROFEMUR® — Microport Orthopedics Inc.OsteoBridge™ — Merete GmbH4WEB Medical — 4web MedicalCross-Fuse PEEK IBF System — Pioneer Surgical Technology, Inc.Vanguard® — Biomet Orthopedics, LLCMultiPolar® — Zimmer, Inc.
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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