Device recall: 14cm QD Angle Attachment Product Usage: Product attachment

Class II FDA enforcement event 76059. Recall start date: 6 Oct 2016. Status in the FDA record: Terminated. Termination date: 26 Jul 2019.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

The Anspach Effort, Inc. started this device recall on 6 Oct 2016. The firm address in the FDA record is in Palm Beach Gardens, FL. FDA put the recall in Class II. FDA event 76059 has 103 product records. The first FDA enforcement report date is 10 May 2017. The record gives the status Terminated, with the termination date 26 Jul 2019.

FDA enforcement report The 103 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

The Anspach Effort, Inc., Palm Beach Gardens, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

103 product records in the event.

FDA event 76059: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1930-2017	14cm QD Angle Attachment Product Usage: Product attachment		Class II	Terminated	10 May 2017
Z-1931-2017	AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system	19	Class II	Terminated	10 May 2017
Z-1932-2017	AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system	17	Class II	Terminated	10 May 2017
Z-1933-2017	Foot control irrigation system Product Usage: Pneumatic system	1	Class II	Terminated	10 May 2017
Z-1934-2017	Autolube-III Product Usage: Pneumatic system	239	Class II	Terminated	10 May 2017
Z-1935-2017	Autolube-III with 20ft hose Product Usage: Pneumatic system	16	Class II	Terminated	10 May 2017
Z-1936-2017	AL-III-DISS Adapter Product Usage: Pneumatic system	5	Class II	Terminated	10 May 2017
Z-1937-2017	Autolube-III with Foot Guard Product Usage: Pneumatic system	17	Class II	Terminated	10 May 2017
Z-1938-2017	Autolube-III with Irrigation Product Usage: Pneumatic system	51	Class II	Terminated	10 May 2017
Z-1939-2017	Autolube-III with NK Product Usage: Pneumatic system	1	Class II	Terminated	10 May 2017
Z-1940-2017	19cm Attachment, Black Max Product Usage: Pneumatic system	41	Class II	Terminated	10 May 2017
Z-1941-2017	BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system	25	Class II	Terminated	10 May 2017
Z-1942-2017	IMRI AIR CONTROL Product Usage: Pneumatic system	3	Class II	Terminated	10 May 2017
Z-1943-2017	IMRI MOTOR Product Usage: Pneumatic system	3	Class II	Terminated	10 May 2017
Z-1944-2017	XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system	554	Class II	Terminated	10 May 2017
Z-1945-2017	XMAX Motor, High Strength Hose Product Usage: Pneumatic system	22	Class II	Terminated	10 May 2017
Z-1946-2017	Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system	207	Class II	Terminated	10 May 2017
Z-1947-2017	Electric Handpiece EM Hand Control Product Usage: Electric system	32	Class II	Terminated	10 May 2017
Z-1948-2017	Electronic Foot Control with Direction Switch Product Usage: Electric system	209	Class II	Terminated	10 May 2017
Z-1949-2017	Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system	821	Class II	Terminated	10 May 2017
Z-1950-2017	eMax2 Motor Assembly Product Usage: Electric system	158	Class II	Terminated	10 May 2017
Z-1951-2017	eMax2 Hybrid Hand Control Product Usage: Electric system	293	Class II	Terminated	10 May 2017
Z-1952-2017	eMax2 PLUS Product Usage: Electric system	3,434	Class II	Terminated	10 May 2017
Z-1953-2017	Foot Control, SC2100 Product Usage: Electric system	320	Class II	Terminated	10 May 2017
Z-1954-2017	Foot Control without Switches, SC2100 Product Usage: Electric system	22	Class II	Terminated	10 May 2017
Z-1955-2017	Console, eMax2 Plus Product Usage: Electric system	439	Class II	Terminated	10 May 2017
Z-1956-2017	System Console, Single Port, with irrigation Product Usage: Electric system	462	Class II	Terminated	10 May 2017
Z-1957-2017	System Console, Single Port, no irrigation	239	Class II	Terminated	10 May 2017
Z-1958-2017	7.2cm Adjustable Drill Guide Product Usage: Electric system	198	Class II	Terminated	10 May 2017
Z-1959-2017	19CM ATTACHMENT, BLACK MAX	41	Class II	Terminated	10 May 2017
Z-1960-2017	11.25CM ATTACHMENT, BLACK MAX	216	Class II	Terminated	10 May 2017
Z-1961-2017	LARGE CRANIOTOME, BLACK MAX	31	Class II	Terminated	10 May 2017
Z-1962-2017	STANDARD CRANIOTOME, BLACK MAX	148	Class II	Terminated	10 May 2017
Z-1963-2017	GREEN ROTATING CRANIOTOME, BLACK MAX	8	Class II	Terminated	10 May 2017
Z-1964-2017	ADJUSTABLE DRILL GUIDE, BLACK MAX	6	Class II	Terminated	10 May 2017
Z-1965-2017	16CM MIN INVASIVE ATTACH, BLACK MAX	4	Class II	Terminated	10 May 2017
Z-1966-2017	KEYLESS DRIVER, BLACK MAX	5	Class II	Terminated	10 May 2017
Z-1967-2017	22CM MICRO REVISION ATTACH, BLACK MAX	25	Class II	Terminated	10 May 2017
Z-1968-2017	16.5CM MICRO REVISION ATTACH, BLACK MAX	17	Class II	Terminated	10 May 2017
Z-1969-2017	9.4CM MICRO REVISION ATTACH, BLACK MAX	11	Class II	Terminated	10 May 2017
Z-1970-2017	CONTRA ANGLE ATTACHMENT, BLACK MAX	2	Class II	Terminated	10 May 2017
Z-1971-2017	90 DEG RIGHT ANGLE ATTACH, BLACK MAX	10	Class II	Terminated	10 May 2017
Z-1972-2017	11CM ANGLE ATTACHMENT, BLACK MAX	45	Class II	Terminated	10 May 2017
Z-1973-2017	10.5CM ANGLE ATTACHMENT, BLACK MAX	13	Class II	Terminated	10 May 2017
Z-1974-2017	14CM ANGLE ATTACHMENT, BLACK MAX	17	Class II	Terminated	10 May 2017
Z-1975-2017	13.5CM ANGLE ATTACHMENT, BLACK MAX	1	Class II	Terminated	10 May 2017
Z-1976-2017	8CM ANGLE ATTACHMENT, BLACK MAX	1	Class II	Terminated	10 May 2017
Z-1977-2017	7.5CM ANGLE ATTACHMENT, BLACK MAX	3	Class II	Terminated	10 May 2017
Z-1978-2017	26.65CM ATTACHMENT, BLACK MAX	16	Class II	Terminated	10 May 2017
Z-1979-2017	B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system	5	Class II	Terminated	10 May 2017
Z-1980-2017	6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system	297	Class II	Terminated	10 May 2017
Z-1981-2017	12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system	297	Class II	Terminated	10 May 2017
Z-1982-2017	5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system	49	Class II	Terminated	10 May 2017
Z-1983-2017	PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system	3	Class II	Terminated	10 May 2017
Z-1984-2017	8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system	80	Class II	Terminated	10 May 2017
Z-1985-2017	6.8cm Controlled Depth Attachment Product Usage: Pneumatic system	4	Class II	Terminated	10 May 2017
Z-1986-2017	Adult Craniotome Product Usage: Pneumatic system	2878	Class II	Terminated	10 May 2017
Z-1987-2017	6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system	130	Class II	Terminated	10 May 2017
Z-1988-2017	Rotating Adult Craniotome Product Usage: Pneumatic system	49	Class II	Terminated	10 May 2017
Z-1989-2017	Large Craniotome Product Usage: Pneumatic system	930	Class II	Terminated	10 May 2017

The table shows 60 of 103 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 103Median of the firm: 1
Events of the firm on the register: 35

Other events of the firm

Other FDA enforcement events of The Anspach Effort, Inc.
Initiated	Product (first record)	Type	Class	Records
7 Dec 2022	6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cuttin	Device	Class II	9
29 Sep 2017	OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical p	Device	Class II	1
26 Aug 2016	G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.	Device	Class II	4
24 Jun 2016	Light Adaptor for Small Battery Drive and Small Battery Drive II.	Device	Class I	2
15 Jun 2016	Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the crani	Device	Class II	1
28 Mar 2016	ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic C	Device	Class II	2
15 Jan 2016	Universal Battery Charger II (UBC II)	Device	Class II	1
25 Nov 2015	Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.	Device	Class II	1
2 Nov 2015	Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.	Device	Class II	1
1 Jul 2015	Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.	Device	Class II	1

The Anspach Effort, Inc.: all 35 events

Official channels

FDA enforcement report Z-1930-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 76059. https://recallregister.com/fda/ii/76059/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.
How many FDA recalls does The Anspach Effort, Inc. have?: The Anspach Effort, Inc. is the recalling firm in 35 enforcement events on this register. This event is 1 of them.