Tray, Surgical, Instrument
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
2,231 adverse event reports on file
- SOCKET WRENCH WITH STRAIGHT HANDLE-6MM WIDTH ACROSS FLATSJul 28, 2026MalfunctionSynthes Gmbh8030965-2026-07773
- ACTISJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12569
- ACTISJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12568
- ACTISJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12570
- ACTISJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12572
- ACTISJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12571
- GII TIB TRY IMPL IMPACTORJul 27, 2026MalfunctionSmith & Nephew, Inc.1020279-2026-01022
- ATT TIB PREP PLUS-IMPACTJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12714
- UNK Instrument CaseJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12777
- UNK INSTRUMENT CASEJul 21, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12344
Event type breakdown
Recalls
36 recall events for this product code
- Encore Medical, LPOpen, ClassifiedSep 10, 2025
Brand Name: DJO SURGICAL
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Z-2549-2025 · View FDA record ↗ - Medical Action Industries, Inc. 306Open, ClassifiedSep 12, 2024
Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 e
The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN.
Z-3129-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-3015-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedFeb 25, 2024
Medline Kits, trays, and packs labeled as follows:
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Z-1108-2024 · View FDA record ↗ - Aesculap Implant Systems LLCOpen, ClassifiedApr 25, 2023
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended
Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
Z-1430-2023 · View FDA record ↗ - Stradis HealthcareOpen, ClassifiedJan 11, 2023
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Z-0933-2023 · View FDA record ↗ - Stradis HealthcareOpen, ClassifiedJan 11, 2023
Stradis Healthcare TCTR Convenience Kit. Manufactured by 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.
Z-0944-2023 · View FDA record ↗ - Synthes (USA) Products LLCTerminatedDec 21, 2016
Synthes VA Implant Rack for the Compact Distal Radius System
The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.
Z-0867-2017 · View FDA record ↗ - Stryker Craniomaxillofacial DivisionTerminatedOct 8, 2015
Disposable Paper Filter for Sterilization Containers
Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.
Z-0114-2016 · View FDA record ↗ - Zimmer, Inc.TerminatedOct 6, 2015
Zimmer Universal Locking System, Titanium 3.5mm.
It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat
Z-0027-2016 · View FDA record ↗
Registered firms
900 firms currently registered for this product code
Lakong Medical Devices Co., Ltd.
Dongguan Guangdong, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
Richard Wolf Gmbh
KNITTLINGEN Baden-Wurttemberg, DE
Olympus Winter & Ibe Gmbh
HAMBURG, DE
Shanghai Kangqiao Dental Instruments Factory
SHANGHAI, CN
Synergy Health Ede Bv
Venlo Limburg, NL
Industrias Metalicas Los Pinos Sa
ITAGUI Antioquia, CO
Paragon Medical Device (changzhou) Co., Ltd.
Changzhou Jiangsu, CN
3diemme Srl
Cantu Como, IT
D.o.r.c. Dutch Ophthalmic Research Center (international) B.v.
ZUIDLAND Zuid-Holland, NL
Smith & Nephew, Inc.
Memphis, TN, US
Wexler Surgical, Inc.
HOUSTON, TX, US
Infirmary Medical Supplies
Sialkot Punjab, PK
Zimmer Trabecular Metal Technology, Inc.
Parsippany, NJ, US
Synchronis Medical Llc
Romulus, MI, US
Exel Inc. D/b/a Dhl Supply Chain (usa)
Southaven, MS, US
Medfix International, Llc
Tucson, AZ, US
Gynex Corporation
North Richland Hills, TX, US
Foshan Feiyang Medical Equipment Co., Ltd.
Foshan Guangdong, CN
Ortho-med, Inc.
Tigard, OR, US
Shanghai Reach Medical Instrument Co., Ltd
Shanghai, CN
Vehu Medical Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Versah Llc
Jackson, MI, US
Rti Surgical, Inc. (dba Rti Biologics, Inc.)
ALACHUA, FL, US
Nanova Biomaterials Inc
Columbia, MO, US
510(k) clearances
76 clearances for this product code
- General Hospital Supply Corp.May 6, 1997
K971217 · INSTRUMENT TRAY LINER
- Medcare Medical Group, Inc.Aug 9, 1996
K962328 · SINGLE USE INSTRUMENT TRAY
- Riley Medical, Inc.Nov 22, 1994
K944025 · SURGICAL INSTRUMENT TRAY
- Medical Device Inspection Co., Inc.Aug 29, 1991
K912106 · ARTHROSCOPY TRAY
- Medical Device Inspection Co., Inc.Aug 26, 1991
K912053 · OPEN HEART TRAY
- Medical Device Inspection Co., Inc.Aug 20, 1991
K912052 · HEART CATH TRAY
- Medical Device Inspection Co., Inc.Aug 9, 1991
K912104 · MAJOR BASIN TRAY
- Solan Scissors SalesMay 31, 1991
K910570 · SPLINTER TWEEZERS