Home › Device types › FZX
Guide, Surgical, Instrument
FDA product code FZX · Class 1 · General, Plastic Surgery
14,509
Registered devices
8,555
Adverse events
29
Recalls
19
510(k) clearances
Devices with this code
POROUS KNEE — Smith & Nephew, Inc.Endo-Model Knee System - Instruments — WALDEMAR LINK GmbH & Co. KGMaxima™ ACP System — CG MedTech Co.,Ltd.RIBFIX TITAN — BIOMET MICROFIXATION, INCOPTIMA™ ZS Spinal System — CG MedTech Co.,Ltd.MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMSAPEX Knee System — Omni Life Science, Inc.4WEB Medical — 4web MedicalHumeris Shoulder — FX SOLUTIONSAESCULAP — Aesculap AGNEONAIL — Neoortho Produtos Ortopédicos S/A.Compression Staple System — TORNIER, INC.DJO SURGICAL — Encore Medical, L.P.Natural-Knee® — Zimmer, Inc.ACCU-CUT™ 2mm W/THREADED K-WIRES — BIOPRO, INC.A.L.P.S.® — Biomet Orthopedics, LLCInvictus — ALPHATEC SPINE, INC.Aequalis Reversed II — TORNIERN/A — Ortho Development CorporationDJO SURGICAL — DJO, LLCInTess Lumbar Cage — Kalitec Direct LLCMOTOBAND CP — CROSSROADS EXTREMITY SYSTEMSNA — aap Implantate AGSkyOPS — Sky Surgical, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-30 | Waldemar Link GmbH & Co. KG (Mfg Site) | Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little |
| 2022-10-10 | Hologic, Inc | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set |
| 2019-08-21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| 2019-08-21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| 2019-08-21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| 2018-03-26 | Zimmer Biomet, Inc. | Potential failure of sterile packaging seal. |
| 2017-08-07 | Synthes, Inc. | May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If |
| 2017-04-25 | Cook Inc. | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products |
| 2016-08-09 | Zimmer Biomet, Inc. | Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into t |
| 2016-06-07 | Synthes (USA) Products LLC | DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly la |
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