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Comprehensive® Instrumentation 110029304

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

19 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304734715 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

19 recalls · FDA

    • 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 on shared 510(k) K080642

    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 on shared 510(k) K080642

    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-2549-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • 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-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.

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Comprehensive® Instrumentation
Generic Name
Humeral head prosthesis trial, reusable
Model / Ref / Catalog
110029304
Primary DI / UDI-DI
00880304734715
510(k) Number
FDA Product Code
KWS, PHX
GMDN Term
Humeral head prosthesis trial, reusable
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Humeral head prosthesis trial, reusable

Cleared under the same submission (K080642)

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Cleared under the same submission (K193373)

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Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No