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Comprehensive Reverse Shoulder System SSI004561

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

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 Number00887868251405 UDI-DI Date26 Jul 2018ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · FDA

    • Terminated Z-0093-2021 FDA Class II initiated 2 Sep 2020 on shared 510(k) K120121

    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-1615-2020 FDA Class II initiated 25 Feb 2020 on shared 510(k) K120121

    Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.

    • Terminated Z-0972-2019 FDA Class II initiated 21 Dec 2018

    The product was potentially being packaged without a taper adapter.

    • Terminated Z-1208-2015 FDA Class II initiated 7 Jan 2015

    The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.

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  • Withdrawn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 Reverse Shoulder System
Generic Name
Shoulder glenoid fossa prosthesis trial
Model / Ref / Catalog
SSI004561
Primary DI / UDI-DI
00887868251405
510(k) Number
FDA Product Code
KWS
GMDN Term
Shoulder glenoid fossa prosthesis trial
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Shoulder glenoid fossa prosthesis trial

Cleared under the same submission (K120121)

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