CONCORDE LIFT 2878-04-113Recalls & reported problems

Medos International Sàrl · CONCORDE LIFT INSTRUMENTS SMALL GRAFT DELIVERY · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034531267), received between Oct 19, 2020 and Oct 19, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Material Twisted/Bent1

Patient problems

No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 19, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE CONCORD LIFT GRAFT DELIVERY WAS BENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE, AND IS BEING RETURNED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CONCORDE LIFT GRAFT DELIVERY - SM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10696638 ↗

Device details

UDI-DI	`10705034531267`
Brand	CONCORDE LIFT
Model	2878-04-113
Catalog no.	287804113
Company	Medos International Sàrl
Product code	LXH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 24, 2026

Device type (GMDN): Orthopaedic inorganic implant inserter/extractor, reusable

A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

AML EXCEL 2001-42-000
Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
2,009 reports
NA 03.010.523
Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
1,208 reports
EXPRESSEW 214141
Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
1,166 reports
N/A 9560524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
866 reports
INHANCE 6500-11-104
Depuy (Ireland) · Orthopedic manual surgical instrument
831 reports
INHANCE 6500-11-102
Depuy (Ireland) · Orthopedic manual surgical instrument
567 reports
R3 71364450
Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
520 reports
N/A 9561524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
494 reports

All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page