Biomet® Knee System, product family

Manufacturer

Biomet Orthopedics, Inc.(18)

Basic UDI-DI

889024AWD2X

Risk class

Class II

Legislation

—

EMDN category

—

Market status

18 on the market

Official record

EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 889024AWD2X.

• Z-0938-2019 ·Class II · terminated · 21 Dec 2018
  Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
• Z-2289-2018 ·Class II · terminated · 24 May 2018
  Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.
• Z-2177-2018 ·Class II · terminated · 18 May 2018
  One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
• Z-2183-2018 ·Class II · terminated · 11 May 2018
  The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
• Z-1219-2017 ·Class II · terminated · 15 Dec 2016
  Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
• Z-1756-2015 ·Class III · terminated · 16 Apr 2015
  Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
• Z-2104-2011 ·unclassified · terminated · 3 Mar 2011
  The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
• Z-0706-2008 ·unclassified · terminated · 12 Dec 2007
  Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
• Z-0707-2008 ·unclassified · terminated · 12 Dec 2007
  Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
• Z-0255-2008 ·unclassified · terminated · 18 Sep 2007
  Mislabeled as to size: the package actaully contained a 71 mm tray.

Recalls matched to the 18 devices listed on this page; other pages of the family can carry others.