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Na MIA16

by Synthes GUDID

Listed FDA GUDID listing, not in commercial distribution Open recall

Regulatory status

as of 29 Oct 2026

Recall ongoing. 9 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00845384005070 UDI-DIDate5 Feb 2018ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

70 recalls · 9 ongoing · FDA

  • 9 recalls, same reason

    • Ongoing Z-0922-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0917-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0921-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0923-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0918-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0920-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0924-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0919-2023 FDA Class II initiated 7 Dec 2022
    • Ongoing Z-0916-2023 FDA Class II initiated 7 Dec 2022

    Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury

  • 33 recalls, same reason

    • Terminated Z-2013-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1951-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-2020-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2028-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2000-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2025-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2022-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2027-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2012-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1932-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2014-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2030-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1986-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2002-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2024-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1933-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1987-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1953-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-1990-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2023-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-2029-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1930-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-1950-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-1985-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1947-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-1954-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-1988-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1994-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1946-2017 FDA Class II initiated 6 Oct 2016
    • Terminated Z-1931-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1958-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1991-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444
    • Terminated Z-1999-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K011444

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

    • Terminated Z-1574-2014 FDA Class II initiated 8 Jan 2014 on shared 510(k) K011444

    Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

    • Terminated Z-0779-2014 FDA Class II initiated 6 May 2013

    Product did not reach expected sterility assurance level

  • 12 recalls, same reason

    • Terminated Z-1905-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1896-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1911-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1895-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1910-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1899-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1912-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1909-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1908-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1917-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1904-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1913-2014 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 on shared 510(k) K011444
    • Terminated Z-0075-2013 FDA Class II initiated 9 Jan 2012 on shared 510(k) K011444
    • Terminated Z-0076-2013 FDA Class II initiated 9 Jan 2012 on shared 510(k) K011444

    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.

  • 3 recalls, same reason

    • Terminated Z-3191-2011 FDA Unclassified (pre-2012) initiated 9 May 2011
    • Terminated Z-3189-2011 FDA Unclassified (pre-2012) initiated 9 May 2011
    • Terminated Z-3190-2011 FDA Unclassified (pre-2012) initiated 9 May 2011

    The Anspach Effort, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #'s C323023789, C403026551, C473028567, C403026563, D153034013, D173034385, and C363024789, because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to

    • Terminated Z-0198-2014 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

  • 2 recalls, same reason

    • Terminated Z-0830-2014 FDA Class II initiated 31 Mar 2011 on shared 510(k) K011444
    • Terminated Z-0829-2014 FDA Class II initiated 31 Mar 2011

    Cutter was longer than was stated on the label

  • 2 recalls, same reason

    • Terminated Z-3202-2011 FDA Unclassified (pre-2012) initiated 17 Mar 2011
    • Terminated Z-3203-2011 FDA Unclassified (pre-2012) initiated 17 Mar 2011

    The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr being 2.0 mm longer than stated on the label. As a result, a hole drilled using this burr would be 2 mm deeper than the screw.

    • Terminated Z-0083-2010 FDA Unclassified (pre-2012) initiated 13 Aug 2009 on shared 510(k) K011444

    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

    • Terminated Z-1008-2007 FDA Unclassified (pre-2012) initiated 18 May 2007 on shared 510(k) K011444

    The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.

    • Terminated Z-1243-03 FDA Unclassified (pre-2012) initiated 23 Apr 2003

    Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.

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

Specification

GUDID

Generic Name
Burring power tool attachment
Model / Ref / Catalog
MIA16
Primary DI / UDI-DI
00845384005070
510(k) Number
FDA Product Code
HBC, ERL
GMDN Term
Burring power tool attachment
Device Class
Class II
Regulation Number
882.4360, 874.4250
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

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