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Comprehensive Reverse Shoulder 115383

by Biomet Orthopedics, Inc.

Comprehensive Reverse Shoulder 115383 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K130390 on 9 Oct 2013 (1 earlier submission) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304475540), active as of 23 Oct 2026. 18 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

18 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304475540 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130390 Date9 Oct 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130390 decided 9 Oct 2013 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304475540 listed 24 Oct 2015 Listed

Recalls

18 recalls · FDA

    • 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.

    • Terminated Z-2144-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • Terminated Z-1750-2020 FDA Class II initiated 13 Mar 2020

    There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.

    • Terminated Z-1859-2017 FDA Class II initiated 17 Feb 2017

    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

    • Terminated Z-1103-2017 FDA Class I initiated 20 Dec 2016

    Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.

    • Terminated Z-1548-2013 FDA Class II initiated 15 May 2013

    Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.

  • 10 recalls, same reason

    • Terminated Z-2541-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2549-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2548-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2547-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2550-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2546-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2542-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2545-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2544-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011
    • Terminated Z-2543-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011

    The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.

  • 2 recalls, same reason

    • Terminated Z-0712-2011 FDA Unclassified (pre-2012) initiated 13 Sep 2010
    • Terminated Z-0713-2011 FDA Unclassified (pre-2012) initiated 13 Sep 2010

    The firm received complaints regarding fracturing of the device.

Timeline

21 dated events

  1. Recall initiated FDA recalls Z-2544-2011
  2. Recall initiated FDA recalls Z-2543-2011
  3. Recall initiated FDA recalls Z-1548-2013
  4. Cleared FDA 510(k) K130390
  5. Listed FDA GUDID 00880304475540
  6. Recall initiated FDA recalls Z-1103-2017
  7. Recall initiated FDA recalls Z-1859-2017
  8. Recall initiated FDA recalls Z-1750-2020
  9. Recall initiated FDA recalls Z-2144-2020
  10. Recall initiated FDA recalls Z-0619-2021

11 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Comprehensive Reverse Shoulder
Generic name
Shoulder prosthesis screw
Model / Ref / Catalog
115383
Primary DI / UDI-DI
00880304475540
510(k) Number
FDA product code
KWS, PAO, MBF, KWT, PHX
GMDN term
Shoulder prosthesis screw
Device class
Class II
Regulation number
888.3660, 888.3670, 888.3650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Shoulder prosthesis screw

Cleared under the same submission (K080642)

and 8 more cleared under K080642

Cleared under the same submission (K130390)

and 8 more cleared under K130390

Similar devices in this category

Other devices filed under Shoulder prosthesis screw.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)