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Comprehensive Shoulder System 407324

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

6 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 Number00880304479852 UDI-DI Date20 Mar 2017ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · FDA

    • Terminated Z-1543-2020 FDA Class II initiated 17 Feb 2020

    A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

    • Terminated Z-0591-2019 FDA Class II initiated 10 Oct 2018

    Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.

  • 2 recalls, same reason

    • Terminated Z-0979-2018 FDA Class II initiated 8 Dec 2017
    • Terminated Z-0980-2018 FDA Class II initiated 8 Dec 2017

    Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.

    • Terminated Z-0299-2018 FDA Class II initiated 5 Jun 2017

    Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

    • Terminated Z-1755-2015 FDA Class III initiated 16 Apr 2015

    Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Comprehensive Shoulder System
Generic Name
Humeral head prosthesis trial, reusable
Model / Ref / Catalog
407324
Primary DI / UDI-DI
00880304479852
510(k) Number
FDA Product Code
MBF, KWS, HSD, KWT
GMDN Term
Humeral head prosthesis trial, reusable
Device Class
Class II
Regulation Number
888.3670, 888.3660, 888.3690, 888.3650
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 (K060692)

Show all (12)

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