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Screw System 113847

by Biomet Orthopedics, Inc.

Screw System 113847 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K030710 on 4 Jun 2003 (3 earlier submissions) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304213982), active as of 23 Oct 2026. 3 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

4 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304213982 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK030710 Date4 Jun 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K030710 decided 4 Jun 2003 Active· +3 more in the status table
  • FDA GUDID UDI-DI 00880304213982 listed 24 Oct 2015 Listed

Recalls

4 recalls · FDA

    • Terminated Z-0621-2021 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-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-0474-2013 FDA Class II initiated 1 Nov 2012

    The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.

    • Terminated Z-2135-2011 FDA Unclassified (pre-2012) initiated 10 Mar 2011 on shared 510(k) K991807

    One lot of 30 mm screws was switched with one lot of 25 mm screws.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

9 dated events

  1. Cleared FDA 510(k) K872454
  2. Cleared FDA 510(k) K991807
  3. Cleared FDA 510(k) K992119
  4. Cleared FDA 510(k) K030710
  5. Recall initiated FDA recalls Z-2135-2011
  6. Recall initiated FDA recalls Z-0474-2013
  7. Listed FDA GUDID 00880304213982
  8. Recall initiated FDA recalls Z-1859-2017
  9. Recall initiated FDA recalls Z-0621-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Screw System
Generic name
Shoulder prosthesis screw
Model / Ref / Catalog
113847
Primary DI / UDI-DI
00880304213982
510(k) Number
FDA product code
HSD, LPH, MBF, KWT, KWS
GMDN term
Shoulder prosthesis screw
Device class
Class II
Regulation number
888.3690, 888.3358, 888.3670, 888.3650, 888.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Shoulder prosthesis screw

Cleared under the same submission (K030710)

and 8 more cleared under K030710

Cleared under the same submission (K872454)

and 8 more cleared under K872454

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)