G7 ACETABULAR SCREW, product family

Manufacturer

Biomet Orthopedics, Inc.(9)

Basic UDI-DI

889024AM1YS

Risk class

Class II

Legislation

—

EMDN category

—

Market status

9 on the market

Official record

EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 889024AM1YS.

• Z-0007-2023 ·Class II · ongoing · 25 Aug 2022
  The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.
• Z-1837-2014 ·Class II · terminated · 7 May 2014
  Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
• Z-1838-2014 ·Class II · terminated · 7 May 2014
  Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

Recalls matched to the 9 devices listed on this page; other pages of the family can carry others.