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Comprehensive Shoulder 110005240

by Biomet Orthopedics, Inc.

Comprehensive Shoulder 110005240 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K193038 on 28 Oct 2020 (1 earlier submission) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304567955), active as of 23 Oct 2026. 2 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

1 ongoing

This device is named in the recall

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 NumberK193038 Date28 Oct 2020DecidedStatusActive
United StatesGUDID listing Number00880304567955 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193038 decided 28 Oct 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304567955 listed 24 Oct 2015 Listed

Recalls

2 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-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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K130390
  2. Listed FDA GUDID 00880304567955
  3. Cleared FDA 510(k) K193038
  4. Recall initiated FDA recalls Z-0619-2021
  5. Recall initiated FDA recalls Z-1403-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Comprehensive Shoulder
Generic name
Shoulder glenoid fossa prosthesis, prefabricated
Model / Ref / Catalog
110005240
Primary DI / UDI-DI
00880304567955
510(k) Number
FDA product code
PHX, PAO, MBF, KWT, KWS, HSD
GMDN term
Shoulder glenoid fossa prosthesis, prefabricated
Device class
Class II
Regulation number
888.3660, 888.3670, 888.3650, 888.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Shoulder glenoid fossa prosthesis, prefabricated

Cleared under the same submission (K130390)

and 8 more cleared under K130390

Cleared under the same submission (K193038)

and 8 more cleared under K193038

Similar devices in this category

Other devices filed under Shoulder glenoid fossa prosthesis, prefabricated.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)