Skip to content

Flat WASHER6.5MM 110008363

by Biomet Orthopedics, Inc.

Flat WASHER6.5MM 110008363 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K140891 on 3 Jun 2014 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00887868130977), active as of 22 Oct 2026. 5 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

5 closed

Documents

510(k) K140891

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868130977 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140891 Date3 Jun 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140891 decided 3 Jun 2014 Active
  • FDA GUDID UDI-DI 00887868130977 listed 26 Sep 2016 Listed

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0617-2021 FDA Class II initiated 25 Nov 2020
    • Terminated Z-0618-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

  • 2 recalls, same reason

    • Terminated Z-2304-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2303-2020 FDA Class II initiated 14 May 2020

    Distributed to the field without having completed design history files or design transfer activities

    • Terminated Z-1064-2018 FDA Class II initiated 7 Dec 2017

    One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

Timeline

7 dated events

  1. Cleared FDA 510(k) K140891
  2. Listed FDA GUDID 00887868130977
  3. Recall initiated FDA recalls Z-1064-2018
  4. Recall initiated FDA recalls Z-2304-2020
  5. Recall initiated FDA recalls Z-2303-2020
  6. Recall initiated FDA recalls Z-0617-2021
  7. Recall initiated FDA recalls Z-0618-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Flat WASHER6.5MM
Generic name
Orthopaedic bone washer, sterile
Model / Ref / Catalog
110008363
Primary DI / UDI-DI
00887868130977
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone washer, sterile
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Orthopaedic bone washer, sterile

Cleared under the same submission (K140891)

and 8 more cleared under K140891

Similar devices in this category

Other devices filed under Orthopaedic bone washer, sterile.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)