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Comprehensive Shoulder System 113612

by Biomet Orthopedics, Inc.

Comprehensive Shoulder System 113612 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K060692 on 30 May 2006 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304554139), active as of 23 Oct 2026. 6 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

None ongoing

6 closed

Documents

510(k) K060692

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304554139 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK060692 Date30 May 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060692 decided 30 May 2006 Active
  • FDA GUDID UDI-DI 00880304554139 listed 24 Oct 2015 Listed

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.

Timeline

8 dated events

  1. Cleared FDA 510(k) K060692
  2. Recall initiated FDA recalls Z-1755-2015
  3. Listed FDA GUDID 00880304554139
  4. Recall initiated FDA recalls Z-0299-2018
  5. Recall initiated FDA recalls Z-0979-2018
  6. Recall initiated FDA recalls Z-0980-2018
  7. Recall initiated FDA recalls Z-0591-2019
  8. Recall initiated FDA recalls Z-1543-2020

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 System
Generic name
Coated shoulder humeral stem prosthesis
Model / Ref / Catalog
113612
Primary DI / UDI-DI
00880304554139
510(k) Number
FDA product code
HSD, KWT, MBF, KWS
GMDN term
Coated shoulder humeral stem prosthesis
Device class
Class II
Regulation number
888.3690, 888.3650, 888.3670, 888.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated shoulder humeral stem prosthesis

Cleared under the same submission (K060692)

and 8 more cleared under K060692

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)