Skip to content

Na He-4005-10-Fp

by Anspach Effort, The

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

35 closed

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 Number00845384012313 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

35 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-1948-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-2015-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K080802
    • Terminated Z-2032-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K080802
    • Terminated Z-1949-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-2026-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K080802
    • Terminated Z-2019-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K080802
    • Terminated Z-1957-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K080802
    • Terminated Z-1955-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-2031-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K080802
    • Terminated Z-2001-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K080802
    • Terminated Z-1952-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K080802
    • Terminated Z-1956-2017 FDA Class II initiated 6 Oct 2016

    Supplied Directions for Use (DFU) did not contain a recommended service interval.

  • 4 recalls, same reason

    • Terminated Z-0729-2014 FDA Class II initiated 17 Dec 2013
    • Terminated Z-0728-2014 FDA Class II initiated 17 Dec 2013
    • Terminated Z-0727-2014 FDA Class II initiated 17 Dec 2013
    • Terminated Z-0726-2014 FDA Class II initiated 17 Dec 2013

    Some carbide cutting burr fractured during use.

  • 14 recalls, same reason

    • Terminated Z-1887-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1889-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1881-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1890-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1891-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1892-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1880-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1893-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1879-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1888-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1885-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1878-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1886-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1877-2014 FDA Class II initiated 28 Nov 2012

    The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

  • 3 recalls, same reason

    • Terminated Z-0074-2013 FDA Class II initiated 9 Jan 2012
    • Terminated Z-0075-2013 FDA Class II initiated 9 Jan 2012
    • Terminated Z-0076-2013 FDA Class II initiated 9 Jan 2012

    The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.

    • Terminated Z-0200-2014 FDA Class II initiated 6 May 2011

    Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th

    • Terminated Z-0083-2010 FDA Unclassified (pre-2012) initiated 13 Aug 2009

    The Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions which could possibly cause interference on other electrical equipment adjacent to the foot pedal

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

Generic Name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Model / Ref / Catalog
HE-4005-10-FP
Primary DI / UDI-DI
00845384012313
510(k) Number
FDA Product Code
HBF, GEY, HBE
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Device Class
Class II
Regulation Number
882.4305, 878.4820, 882.4310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Other devices from The Anspach Effort, Inc.

See all devices from The Anspach Effort, Inc. →

Properties

Other properties (14)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No