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Vanguard®, product family

by Biomet Orthopedics, Inc. 20 variants Basic UDI-DI 889024BDS29

Shared by every variant

Manufacturer
Biomet Orthopedics, Inc.(20)
Basic UDI-DI
889024BDS29
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 889024BDS29.

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 889024BDS29
UDI-DISize and differences
Vanguard® 32-483000 32-483000 / 32-48300000887868490170 —On the market
Vanguard® 32-483002 32-483002 / 32-48300200887868490187 —On the market
Vanguard® 32-483004 32-483004 / 32-48300400887868490194 —On the market
Vanguard® 32-483006 32-483006 / 32-48300600887868490200 —On the market
Vanguard® 32-483008 32-483008 / 32-48300800887868490217 —On the market
Vanguard® 32-483010 32-483010 / 32-48301000887868490224 —On the market
Vanguard® 32-483012 32-483012 / 32-48301200887868490231 —On the market
Vanguard® 32-483013 32-483013 / 32-48301300887868490248 —On the market
Vanguard® 32-483014 32-483014 / 32-48301400887868490255 —On the market
Vanguard® 32-483016 32-483016 / 32-48301600887868490262 —On the market
Vanguard® 32-483020 32-483020 / 32-48302000887868490279 —On the market
Vanguard® 32-483022 32-483022 / 32-48302200887868490286 —On the market
Vanguard® 32-483024 32-483024 / 32-48302400887868490293 —On the market
Vanguard® 32-483026 32-483026 / 32-48302600887868490309 —On the market
Vanguard® 32-483028 32-483028 / 32-48302800887868490316 —On the market
Vanguard® 32-483030 32-483030 / 32-48303000887868490323 —On the market
Vanguard® 32-483032 32-483032 / 32-48303200887868490330 —On the market
Vanguard® 32-483033 32-483033 / 32-48303300887868490347 —On the market
Vanguard® 32-483034 32-483034 / 32-48303400887868490354 —On the market
Vanguard® 32-483036 32-483036 / 32-48303600887868490361 —On the market