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

Device recall: Light Adaptor for Small Battery Drive and Small Battery Drive II.

FDA enforcement event 74835 · Class I · initiated 24 Jun 2016 · status Terminated · terminated 9 Jun 2018

DeviceVoluntary: Firm initiated2 product recordsPalm Beach Gardens, FL

The Anspach Effort, Inc. (Palm Beach Gardens, FL) initiated this device recall on 24 Jun 2016; FDA lists 2 product records under event 74835, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 3% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 9 Jun 2018. 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

"There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst."

Distribution

"Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2783-2016	Light Adaptor for Small Battery Drive and Small Battery Drive II.	1,833 devices (05.001.024 and 05.001.108)	Class I	Terminated	5 Oct 2016
Z-2784-2016	Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can…	1,833 devices (05.001.024 and 05.001.108)	Class I	Terminated	5 Oct 2016

Context

3%of 2016 device events are Class I1,232 events that year

2product 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
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

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: "There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 9 Jun 2018. "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.