Vanguard® 360 Instrument, product family

Manufacturer

Biomet Orthopedics, Inc.(29)

Basic UDI-DI

889024BCZ2L

Risk class

Class II

Legislation

—

EMDN category

—

Market status

29 on the market

Official record

EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 889024BCZ2L.

• Z-0723-2021 ·Class II · terminated · 1 Dec 2020
  Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
• Z-3249-2018 ·Class II · terminated · 2 Aug 2018
  The implant only has one bolt in the sterile package but it should have had two.
• Z-3250-2018 ·Class II · terminated · 2 Aug 2018
  The implant only has one bolt in the sterile package but it should have had two.
• Z-0003-2017 ·Class II · terminated · 8 Aug 2016
  The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.
• Z-2242-2014 ·Class II · terminated · 1 Jul 2014
  The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

Recalls matched to the 29 devices listed on this page; other pages of the family can carry others.