Orthopedic Manual Surgical Instrument
FDA adverse event reports and recall history for orthopedic manual surgical instrument (product code LXH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 80,729
- Deaths
- 55
- Injuries
- 7,511
- Malfunctions
- 72,702
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-04-17Open, ClassifiedDevice Design
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
- 2025-04-17Open, ClassifiedDevice Design
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
- 2025-03-11Open, ClassifiedEmployee error
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Device is missing the pin in the graft loader component.
- 2025-03-11Open, ClassifiedEmployee error
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Device is missing the pin in the graft loader component.
- 2025-01-22Open, ClassifiedDevice Design
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures. Component: No
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
- 2024-11-27Open, ClassifiedProcess change control
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
An out of specification component may result in the device exhibiting torque output higher than the design specification.
- 2024-10-17Open, ClassifiedUnder Investigation by firm
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the implant is to be placed, as supported within the Surgical Technique Guide.
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
- 2024-09-24Open, ClassifiedUnder Investigation by firm
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
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.
- 2024-08-29Open, ClassifiedProcess control
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
- 2024-08-20Open, ClassifiedProcess control
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
At least two units have been found to be missing a weld.
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