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Comprehensive 405809

by Biomet Orthopedics, Inc.

Comprehensive 405809 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K193373 on 15 Apr 2020 (2 earlier submissions) and listed in FDA GUDID since 27 Oct 2016 (UDI-DI 00880304532298), active as of 23 Oct 2026. 6 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

6 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 NumberK193373 Date15 Apr 2020DecidedStatusActive
United StatesGUDID listing Number00880304532298 UDI-DI Date27 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193373 decided 15 Apr 2020 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00880304532298 listed 27 Oct 2016 Listed

Recalls

6 recalls · FDA

    • Terminated Z-1131-2021 FDA Class II initiated 15 Jan 2021

    Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.

    • Terminated Z-0619-2021 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.

    • Terminated Z-0093-2021 FDA Class II initiated 2 Sep 2020

    Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

    • Terminated Z-1615-2020 FDA Class II initiated 25 Feb 2020

    Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.

    • Terminated Z-0972-2019 FDA Class II initiated 21 Dec 2018

    The product was potentially being packaged without a taper adapter.

    • Terminated Z-1208-2015 FDA Class II initiated 7 Jan 2015

    The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.

Timeline

10 dated events

  1. Cleared FDA 510(k) K120121
  2. Cleared FDA 510(k) K132239
  3. Recall initiated FDA recalls Z-1208-2015
  4. Listed FDA GUDID 00880304532298
  5. Recall initiated FDA recalls Z-0972-2019
  6. Recall initiated FDA recalls Z-1615-2020
  7. Cleared FDA 510(k) K193373
  8. Recall initiated FDA recalls Z-0093-2021
  9. Recall initiated FDA recalls Z-0619-2021
  10. Recall initiated FDA recalls Z-1131-2021

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Comprehensive
Generic name
Orthopaedic implant impactor, reusable
Model / Ref / Catalog
405809
Primary DI / UDI-DI
00880304532298
510(k) Number
FDA product code
KWS, PHX
GMDN term
Orthopaedic implant impactor, reusable
Device class
Class II
Regulation number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant impactor, reusable

Cleared under the same submission (K120121)

and 8 more cleared under K120121

Cleared under the same submission (K132239)

and 8 more cleared under K132239

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)