Home › Device types › FSM
Tray, Surgical, Instrument
FDA product code FSM · Class 1 · General, Plastic Surgery
31,143
Registered devices
2,231
Adverse events
36
Recalls
76
510(k) clearances
Devices with this code
N/A — MEDTRONIC SOFAMOR DANEK, INC.American Eagle Instruments — AMERICAN EAGLE INSTRUMENTS, INC.APTUS — Medartis AGResponse 5.5/6.0 Spine — ORTHOPEDIATRICS CORP.MEMORY STAPLE MODULE — Biomet Orthopedics, LLCVital MIS Spinal Fixation System — Highridge Medical, LLCVital MIS Spinal Fixation System — Highridge Medical, LLCACUMED — Acumed LLCPolaris 5.5 Spinal Fixation System — Highridge Medical, LLCMONDEAL — MONDEAL Medical Systems GmbHLC-DCP — Synthes GmbHLEVEL ONE — KLS-Martin L.P.MSI Precision Specialty Instruments — Med Saver, Inc.DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.ACUMED — Acumed LLCFAICO CMF System — FAICO MEDICAL LLCLID 2 — Bradshaw Medical, Inc.AESCULAP — AESCULAP IMPLANT SYSTEMS, LLCEVOS — Smith & Nephew, Inc.Peri-loc — Smith & Nephew, Inc.ATLANTIS® Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.ELEOS™ — ONKOS SURGICAL, INC.KEYSTONE — DEPUY SPINE, LLCHu-Friedy MFG Co., LLC. — HU-FRIEDY MFG. CO., LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-18 | Encore Medical, LP | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| 2024-06-11 | Medical Action Industries, Inc. 306 | The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) c |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2023-11-15 | MEDLINE INDUSTRIES, LP - Northfield | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr |
| 2023-02-23 | Aesculap Implant Systems LLC | Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| 2021-11-24 | Howmedica Osteonics Corp. | Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemen |
| 2019-06-10 | Zimmer Biomet, Inc. | Lack of an adequate sterilization validation. |
| 2019-06-10 | Zimmer Biomet, Inc. | Lack of an adequate sterilization validation. |
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