[Recalled] MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device — There is a potential for breakage of the small screw used to affix the anti-bac… | FDA 2023-03-08

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There is a potential for breakage of the small screw used to affix the anti-backout plate.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Medacta Usa Inc

• The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF — Class II
• Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery. — Class II
• MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device — Class II
• Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The — Class II
• Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem. — Class II
• GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.