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Biomet Knee System 11-150842

by Biomet Orthopedics, Inc.

Biomet Knee System 11-150842 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K171054 on 28 Jul 2017 (1 earlier submission) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304005174), active as of 23 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

7 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171054 Date28 Jul 2017DecidedStatusActive
United StatesGUDID listing Number00880304005174 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171054 decided 28 Jul 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304005174 listed 24 Oct 2015 Listed

Recalls

7 recalls · FDA

    • Terminated Z-2149-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • 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.

  • 2 recalls, same reason

    • Terminated Z-0077-2008 FDA Unclassified (pre-2012) initiated 24 Jul 2007
    • Terminated Z-0076-2008 FDA Unclassified (pre-2012) initiated 24 Jul 2007

    Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.

Timeline

10 dated events

  1. Cleared FDA 510(k) K921182
  2. Recall initiated FDA recalls Z-0077-2008
  3. Recall initiated FDA recalls Z-0076-2008
  4. Listed FDA GUDID 00880304005174
  5. Cleared FDA 510(k) K171054
  6. Recall initiated FDA recalls Z-2183-2018
  7. Recall initiated FDA recalls Z-2177-2018
  8. Recall initiated FDA recalls Z-2289-2018
  9. Recall initiated FDA recalls Z-0938-2019
  10. Recall initiated FDA recalls Z-2149-2020

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
Polyethylene patella prosthesis
Model / Ref / Catalog
11-150842
Primary DI / UDI-DI
00880304005174
510(k) Number
FDA product code
HRY, JWH, MBH, MBV, OIY
GMDN term
Polyethylene patella prosthesis
Device class
Class II
Regulation number
888.3530, 888.3560, 888.3565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polyethylene patella prosthesis

Cleared under the same submission (K171054)

and 8 more cleared under K171054

Cleared under the same submission (K921182)

and 8 more cleared under K921182

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
Other properties (9, all answered No)