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Comprehensive® Shoulder System 113055

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304461598 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 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.

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  • Withdrawn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
Stem-fixed metallic humeral head prosthesis
Model / Ref / Catalog
113055
Primary DI / UDI-DI
00880304461598
510(k) Number
FDA Product Code
KWT, MBF, KWS, HSD
GMDN Term
Stem-fixed metallic humeral head prosthesis
Device Class
Class II
Regulation Number
888.3650, 888.3670, 888.3660, 888.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stem-fixed metallic humeral head prosthesis

Cleared under the same submission (K060716)

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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