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

Device recall: Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.

FDA enforcement event 73197 · Class II · initiated 2 Nov 2015 · status Terminated · terminated 6 May 2016

DeviceVoluntary: Firm initiated1 product recordPalm Beach Gardens, FL

The Anspach Effort, Inc. (Palm Beach Gardens, FL) initiated this device recall on 2 Nov 2015; FDA lists 1 product record under event 73197, 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 6 May 2016. 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

"Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498)."

Distribution

"Distributed in the states of PA and MN, and the country of Switzerland."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1246-2016	Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.	50 clips	Class II	Terminated	30 Mar 2016

Context

91%of 2015 device events are Class II1,153 events that year

1product record 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
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: "Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498)."

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: "Distributed in the states of PA and MN, and the country of Switzerland."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 6 May 2016. "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.