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Vanguard®, product family

by Biomet Orthopedics, Inc. 20 variants Basic UDI-DI 889024BDR27

Shared by every variant

Manufacturer
Biomet Orthopedics, Inc.(20)
Basic UDI-DI
889024BDR27
Risk class
Class II
Legislation
—
EMDN category
—
Market status
20 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 889024BDR27.

Recalls

7 recalls · 2 ongoing · FDA

  • Z-1042-2023 Class II · ongoing · 29 Dec 2022
    Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
  • Z-1043-2023 Class II · ongoing · 29 Dec 2022
    Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
  • Z-0495-2019 Class II · terminated · 22 Oct 2018
    Label on the outer carton or the patient labels does not match label on the inner sterile packaging
  • Z-0496-2019 Class II · terminated · 22 Oct 2018
    Label on the outer carton or the patient labels does not match label on the inner sterile packaging
  • 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-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-1011-2018 Class II · terminated · 3 Oct 2017
    The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

Recalls matched to the 20 devices listed on this page; other pages of the family can carry others.

Variants

20 devices · page 1 of 1

Variants of Vanguard®, Basic UDI-DI 889024BDR27
UDI-DISize and differences
Vanguard® 32-483100 32-483100 / 32-48310000887868490378 —On the market
Vanguard® 32-483102 32-483102 / 32-48310200887868490385 —On the market
Vanguard® 32-483104 32-483104 / 32-48310400887868490392 —On the market
Vanguard® 32-483106 32-483106 / 32-48310600887868490408 —On the market
Vanguard® 32-483108 32-483108 / 32-48310800887868490415 —On the market
Vanguard® 32-483110 32-483110 / 32-48311000887868490422 —On the market
Vanguard® 32-483112 32-483112 / 32-48311200887868490439 —On the market
Vanguard® 32-483113 32-483113 / 32-48311300887868490446 —On the market
Vanguard® 32-483114 32-483114 / 32-48311400887868490453 —On the market
Vanguard® 32-483116 32-483116 / 32-48311600887868490460 —On the market
Vanguard® 32-483120 32-483120 / 32-48312000887868490477 —On the market
Vanguard® 32-483122 32-483122 / 32-48312200887868490484 —On the market
Vanguard® 32-483124 32-483124 / 32-48312400887868490491 —On the market
Vanguard® 32-483126 32-483126 / 32-48312600887868490507 —On the market
Vanguard® 32-483128 32-483128 / 32-48312800887868490514 —On the market
Vanguard® 32-483130 32-483130 / 32-48313000887868490521 —On the market
Vanguard® 32-483132 32-483132 / 32-48313200887868490538 —On the market
Vanguard® 32-483133 32-483133 / 32-48313300887868490545 —On the market
Vanguard® 32-483134 32-483134 / 32-48313400887868490552 —On the market
Vanguard® 32-483136 32-483136 / 32-48313600887868490569 —On the market