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Biomet Knee Stem Extension Trial 32-341700

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304459694 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

    • Terminated Z-0723-2021 FDA Class II initiated 1 Dec 2020

    Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

  • 2 recalls, same reason

    • Terminated Z-3249-2018 FDA Class II initiated 2 Aug 2018
    • Terminated Z-3250-2018 FDA Class II initiated 2 Aug 2018

    The implant only has one bolt in the sterile package but it should have had two.

    • Terminated Z-0003-2017 FDA Class II initiated 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.

    • Terminated Z-2242-2014 FDA Class II initiated 1 Jul 2014

    The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Biomet Knee Stem Extension Trial
Generic Name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
32-341700
Primary DI / UDI-DI
00880304459694
510(k) Number
FDA Product Code
MBV, JWH
GMDN Term
Knee tibia prosthesis trial, reusable
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Knee tibia prosthesis trial, reusable

Cleared under the same submission (K093293)

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Cleared under the same submission (K121149)

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Other devices from Biomet Orthopedics, Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No