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Comprehensive 405958

by Biomet Orthopedics, Inc.

Comprehensive 405958 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 20 Mar 2017 (UDI-DI 00880304470231), active as of 23 Oct 2026. 20 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

20 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 Number00880304470231 UDI-DI Date20 Mar 2017ListedStatusListed 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 00880304470231 listed 20 Mar 2017 Listed

Recalls

20 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-2144-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • Terminated Z-1750-2020 FDA Class II initiated 13 Mar 2020

    There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.

    • Terminated Z-1859-2017 FDA Class II initiated 17 Feb 2017

    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

    • Terminated Z-1103-2017 FDA Class I initiated 20 Dec 2016

    Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.

    • Terminated Z-1548-2013 FDA Class II initiated 15 May 2013

    Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.

  • 10 recalls, same reason

    • Terminated Z-2548-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2547-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2550-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2546-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2542-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2545-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2541-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2549-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2544-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2543-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011

    The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.

  • 2 recalls, same reason

    • Terminated Z-0712-2011 FDA Unclassified (pre-2012) initiated 13 Sep 2010
    • Terminated Z-0713-2011 FDA Unclassified (pre-2012) initiated 13 Sep 2010

    The firm received complaints regarding fracturing of the device.

Timeline

24 dated events

  1. Cleared FDA 510(k) K132239
  2. Recall initiated FDA recalls Z-1103-2017
  3. Recall initiated FDA recalls Z-1859-2017
  4. Listed FDA GUDID 00880304470231
  5. Recall initiated FDA recalls Z-1750-2020
  6. Cleared FDA 510(k) K193373
  7. Recall initiated FDA recalls Z-2144-2020
  8. Recall initiated FDA recalls Z-0093-2021
  9. Recall initiated FDA recalls Z-0619-2021
  10. Recall initiated FDA recalls Z-1131-2021

14 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
Comprehensive
Generic name
Humeral head prosthesis trial, reusable
Model / Ref / Catalog
405958
Primary DI / UDI-DI
00880304470231
510(k) Number
FDA product code
PAO, KWS, HWT, PHX
GMDN term
Humeral head prosthesis trial, reusable
Device class
Class II
Regulation number
888.3660, 888.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Humeral head prosthesis trial, reusable

Cleared under the same submission (K080642)

and 8 more cleared under K080642

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
Other properties (12, all answered No)