LHXClass II

Trousers, Anti-shock

Cardiovascular · 21 CFR 870.5800

MDR events102All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances4All time

Recent MDR events

102 adverse event reports on file

UNIVERSAL INSERT SPACER SZ 1-2 12MMOct 22, 2025
MalfunctionSmith & Nephew, Inc.1020279-2025-01753
UNIVERSAL INSERT SPACER SZ 1-2 12MMNov 26, 2024
MalfunctionSmith & Nephew, Inc.1020279-2024-02478
IBALANCE TKA, MODULAR T-HANDLEMay 31, 2024
MalfunctionArthrex, Inc.1220246-2024-04588
NUVASIVE GENERAL INSTRUMENTSMay 16, 2024
MalfunctionNuvasive, Incorporated2031966-2024-00139
UNKNOWN GLENOIDDec 21, 2023
InjuryZimmer Biomet, Inc.0001822565-2023-03748
NUVASIVE GENERAL INSTRUMENTSMay 23, 2023
MalfunctionNuvasive, Incorporated2031966-2023-00114
NUVASIVE GENERAL INSTRUMENTSApr 27, 2023
MalfunctionNuvasive, Incorporated2031966-2023-00094
QUADRA GENERAL SCREWED STEM EXTRACTOR M8Apr 25, 2023
MalfunctionMedacta International Sa3005180920-2023-00301
AMIS LEG POSITIONER 2.0 FRAMEMar 29, 2023
InjuryMedacta International Sa3005180920-2023-00192
NUVASIVE GENERAL INSTRUMENTSMar 15, 2023
MalfunctionNuvasive, Incorporated2031966-2023-00045

Event type breakdown

Malfunction84

Injury18

Most-reported manufacturers

Depuy France Sas 300389557518 Nuvasive, Incorporated13 Zimmer Biomet, Inc.11 Depuy Mitek9 Depuy Orthopaedics, Inc.9 Smith & Nephew, Inc.9 Medacta International Sa4 Depuy Orthopaedics, Inc. 18189103

Recalls

1 recall events for this product code

Stryker Spine
TerminatedFeb 16, 2010
Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteon
Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.
Z-0792-2010 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

Allied Medical Llc
Earth City, MO, US

510(k) clearances

4 clearances for this product code