LCU Hip System - Instruments 130-394/01Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Surgical instrument handle, non-torque-limiting - General instrument · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04026575215539), received between Aug 21, 2024 and Mar 6, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Sep 11, 2024Open, Classified
Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.
Z-3245-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2025Fracture; Fracture
THE UNIVERSAL HANDLE BROKE DURING SURGERY. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21537231 ↗MalfunctionSep 5, 2024Fracture; Fracture
THE UNVIVERSAL HANDLE BROKE DURING A WORKSHOP. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20144429 ↗MalfunctionAug 21, 2024Fracture; Fracture
THE UNVIVERSAL HANDLE BROKE DURING SURGERY. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20022092 ↗MalfunctionAug 21, 2024Fracture; Fracture
THE UNIVERSAL HANDLE BROKE DURING SURGERY. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20021914 ↗MalfunctionAug 21, 2024Fracture; Fracture
THE UNVIVERSAL HANDLE BROKE DURING SURGERY. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20020685 ↗
Other Orthopedic manual surgical instrument devices
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.