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Guide, Surgical, Instrument
FDA product code FZX · Class 1 · General, Plastic Surgery
14,296
Registered devices
8,484
Adverse events
29
Recalls
19
510(k) clearances
Devices with this code
MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMSDJO SURGICAL — DJO, LLCPersona — Zimmer, Inc.APEX Knee System — Omni Life Science, Inc.VANGUARD PATELLA SAW GUIDE — Biomet Orthopedics, LLCUNIVERSAL PRECISION CURVED AIMER — Biomet Orthopedics, LLCLINK Instruments - Alignment and positioning instruments — WALDEMAR LINK GmbH & Co. KGTatum Socket Guide 6.0mm — Suncoast Dental, IncDJO SURGICAL — Encore Medical, L.P.Innomed, Inc. — INNOMED, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONAPEX Knee System — Omni Life Science, Inc.LOQTEQ® — aap Implantate AGMICRO-MILL® NexGen® — Zimmer, Inc.PLDF Backpack Right — Osteocentric Technologies, Inc.GENERIC Surgical Instruments — CTL Medical Corporation3S Hemi — Trilliant Surgical, LLCComprehensive® Reverse Shoulder — Biomet Orthopedics, LLCAPEX 3D Total Ankle Replacement System — Paragon 28, Inc.Baby Gorilla/Gorilla Plating System — Paragon 28, Inc.ADVANCE® — Microport Orthopedics Inc.MaxLock — TORNIER, INC.DJO SURGICAL — Encore Medical, L.P.DJO SURGICAL — Encore Medical, L.P.
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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