Skip to content

Biomet® Knee System 141484

by Biomet Orthopedics, Inc.

Biomet® Knee System 141484 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K171054 on 28 Jul 2017 (2 earlier submissions) and listed in FDA GUDID since 29 Dec 2017 (UDI-DI 00887868230783), active as of 22 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868230783 UDI-DI Date29 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171054 Date28 Jul 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171054 decided 28 Jul 2017 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00887868230783 listed 29 Dec 2017 Listed

Recalls

8 recalls · FDA

    • Terminated Z-0938-2019 FDA Class II initiated 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.

    • Terminated Z-2289-2018 FDA Class II initiated 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.

    • Terminated Z-2177-2018 FDA Class II initiated 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.

    • Terminated Z-2183-2018 FDA Class II initiated 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.

    • Terminated Z-1219-2017 FDA Class II initiated 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.

    • Terminated Z-1756-2015 FDA Class III initiated 16 Apr 2015

    Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

    • Terminated Z-0533-2013 FDA Class II initiated 15 Nov 2012

    Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes, potentially exposing the patient to the increased risks from being under anesthesia for a longer duration.

    • Terminated Z-1061-2009 FDA Unclassified (pre-2012) initiated 13 Feb 2009 on shared 510(k) K010212

    A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

12 dated events

  1. Recall initiated FDA recalls Z-0533-2013
  2. Cleared FDA 510(k) K142933
  3. Recall initiated FDA recalls Z-1756-2015
  4. Recall initiated FDA recalls Z-1219-2017
  5. Cleared FDA 510(k) K171054
  6. Listed FDA GUDID 00887868230783
  7. Recall initiated FDA recalls Z-2183-2018
  8. Recall initiated FDA recalls Z-2177-2018
  9. Recall initiated FDA recalls Z-2289-2018
  10. Recall initiated FDA recalls Z-0938-2019

2 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Biomet® Knee System
Generic name
Uncoated knee tibia prosthesis, metallic
Model / Ref / Catalog
141484
Primary DI / UDI-DI
00887868230783
510(k) Number
FDA product code
HRY, MBV, MBH, JWH, OIY
GMDN term
Uncoated knee tibia prosthesis, metallic
Device class
Class II
Regulation number
888.3530, 888.3560, 888.3565
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Uncoated knee tibia prosthesis, metallic

Cleared under the same submission (K010212)

and 8 more cleared under K010212

Cleared under the same submission (K142933)

and 8 more cleared under K142933

Similar devices in this category

Other devices filed under Uncoated knee tibia prosthesis, metallic.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)