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Comprehensive® Shoulder System 113645

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868267895 UDI-DI Date30 Aug 2019ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · 1 ongoing · FDA

    • Ongoing Z-1403-2025 FDA Class II initiated 3 Mar 2025

    Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

    • 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-0980-2018 FDA Class II initiated 8 Dec 2017
    • Terminated Z-0979-2018 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
Coated shoulder humeral stem prosthesis
Model / Ref / Catalog
113645
Primary DI / UDI-DI
00887868267895
510(k) Number
FDA Product Code
KWT, MBF, KWS, HSD
GMDN Term
Coated shoulder humeral stem prosthesis
Device Class
Class II
Regulation Number
888.3650, 888.3670, 888.3660, 888.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated shoulder humeral stem prosthesis

Cleared under the same submission (K060692)

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Cleared under the same submission (K193038)

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Other devices from Biomet Orthopedics, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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