CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report

Min Invasive Attach, Black Max recalled by The Anspach Effort

The Anspach Effort is recalling Min Invasive Attach, Black Max, distributed nationwide in the US. The recall was initiated on 6 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-MIA16.

Quantity recalled4

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1965-2017
FDA event ID: 76059
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Terminated
Recall initiated: 6 Oct 2016
FDA classified: 4 May 2017
Reported: 10 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Oct 2016	Recall initiated by company
4 May 2017	Classified by FDA	+210 days
10 May 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

16CM MIN INVASIVE ATTACH, BLACK MAX

Where it was distributed

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

Nationwide District of Columbia Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-MIA16.

Where was it sold?

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 76059

This product is part of a recall event; the main page for the event is Keyless Driver recalled by The Anspach Effort.

Reported	Class	Recall	Company	Reason	Where
10 May 2017	CLASS II	Keyless Driver recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	QD Angle Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Electric Handpiece EM Hand Control recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Controlled Depth Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Small Attachment, J-latch recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Imri Air Control recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	QD Angle Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	XMAX Motor, High Strength Hose recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Tapered Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Rotating Adult Craniotome recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Foot Control without Switches, SC2100 recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Standard Craniotome, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	QD Angle Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	System Console, Single Port, with irrigation recalled	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Rotating Large Craniotome recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Blackmax-neuro Low Pressure recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Bearing Sleeve Straight recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Imri Short Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	90 degree Contra Angle Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Foot control irrigation system recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Autolube-III with Foot Guard recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Long Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Autolube-III with Irrigation recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Short Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Large Craniotome recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	QD Angle Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Angle Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Bearing Sleeve Straight recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Autolube-III with 20ft hose recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	eMax2 PLUS recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Reciprocating Micro SAW recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Electronic Foot Control with Direction or Irrigation Switches recalled	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Compact Speed Reducer, 60:1 recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	QD Angle Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Long Attachment, Non-Tapered End recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Long Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Micro Revision Attach, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Contra Angle Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Adjustable Drill Guide, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Bearing Sleeve Straight Taper recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Heavy Duty Medium Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Green Rotating Craniotome, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Angle Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Angle Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	System Console, Single Port, no irrigation recalled	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Heavy Duty Long Heavy Short Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	45 degree Contra Angle Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	90 Deg Right Angle Attach, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Bearing Sleeve Curved recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Imri Crani-a Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	eMax2 Motor Assembly recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Al-iii-diss Adapter recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Angle Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	eMax2 Hybrid Hand Control recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Compact Speed Reducer, 60:1 Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Electronic Foot Control with Direction Switch recalled	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	QD Angle Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Imri Motor recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Foot Control, SC2100 recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Micro Revision Attach, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Autolube-III with NK recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Electronic Foot Control with Direction or Irrigation Switches recalled	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Al-iii W/ male disconnect and 30ft hose recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Adult Craniotome recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Heavy Duty Long Heavy Short Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Heavy Duty Short Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Sagittal Micro-saw recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	XMAX Motor (Pneumatic Drill System) recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Pediatric Craniotome recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	QD Angle Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Oscillating Micro-saw recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Micro Revision Attach, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Large Craniotome, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Keyless Driver, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Angle Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Angle Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Adjustable Drill Guide recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	B-sagittal Assembly recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Minimal Access Straight Driver recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Small Attachment, Jacobs Chuck recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Chuck Driver System recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Console, eMax2 Plus recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Sagittal Saw recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Minimal Access Attachment, Black MAX recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Minimal Access Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Minimally Invasive Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Bearing Sleeve Straight Taper recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Adlt Crani, Thin Ft Plate recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Otologic Curved Micro recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Medium Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Imri Short Hd Attachment recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Attachment, Black Max recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Al-iii W/ male disconnect and 20ft hose recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide
10 May 2017	CLASS II	Bearing Sleeve Curved recalled by The Anspach Effort	The Anspach Effort	Other	Nationwide

More recalls from The Anspach Effort

All 260

Reported	Class	Recall	Company	Reason	Where
18 Jan 2023Device	CLASS II	Adult Craniotome recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Adult Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Adult Craniotome, Thin Foot Plate Attachment recalled	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Adult Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Large Craniotome Attachment Use with XMax¿, microMax recalled	The Anspach Effort	Processing Deviation	Nationwide

Other Other Medical Devices recalls

All 13,778

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16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide