Food, drugs, devices › The Anspach Effort, Inc.

Device recall: "Electric Systems Foot ControlRx Only" Product Usage: Cutting and shaping bone including bones of the spine an

FDA enforcement event 63086 · Class II · initiated 9 Jan 2012 · status Terminated · terminated 16 Sep 2014

DeviceVoluntary: Firm initiated3 product recordsPalm Beach Gardens, FL

The Anspach Effort, Inc. (Palm Beach Gardens, FL) initiated this device recall on 9 Jan 2012; FDA lists 3 product records under event 63086, classified Class II.

FDA defines Class II as 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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 16 Sep 2014. Initiation: voluntary: firm initiated. The Anspach Effort, Inc. has 35 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

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

Reason for recall

"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."

Distribution

"Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0074-2013	"*Electric Systems Foot ControlRx Only*" Product Usage: Cutting and shaping bone including bones of the spine and cranium.	16 units	Class II	Terminated	24 Oct 2012
Z-0075-2013	"*Electric Systems Foot Control with Direction OnlyRx Only**" Product Usage: Cutting and shaping bone including bones of the spine and cranium.	41 units	Class II	Terminated	24 Oct 2012
Z-0076-2013	"*Electric Systems Foot Control with Direction and IrrigationRx Only**" Product Usage: Cutting and shaping bone including bones of the spine and cranium.	10 units	Class II	Terminated	24 Oct 2012

Context

88%of 2012 device events are Class II823 events that year

3product records in this eventfirm median: 1

35events on this register for the firm

Other enforcement events for 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 cutt	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
6 Oct 2016	14cm QD Angle Attachment Product Usage: Product attachment	Device	Class II	103
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

All 35 events for The Anspach Effort, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 16 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.