Device recall: ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.

Class II FDA enforcement event 71212. Recall start date: 13 Apr 2015. Status in the FDA record: Terminated. Termination date: 25 Aug 2016.

Reason for recall, in the words of FDA

G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.

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 13 Apr 2015. The firm address in the FDA record is in Palm Beach Gardens, FL. FDA put the recall in Class II. FDA event 71212 has 34 product records. The first FDA enforcement report date is 5 Aug 2015. The record gives the status Terminated, with the termination date 25 Aug 2016.

FDA enforcement report The 34 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 including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.

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

34 product records in the event.

FDA event 71212: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2280-2015	ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.	65 tools.	Class II	Terminated	5 Aug 2015
Z-2281-2015	ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone including spine and cranium.	138 tools.	Class II	Terminated	5 Aug 2015
Z-2282-2015	ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.	88 tools.	Class II	Terminated	5 Aug 2015
Z-2283-2015	ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.	177 tools	Class II	Terminated	5 Aug 2015
Z-2284-2015	ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.	227 tools.	Class II	Terminated	5 Aug 2015
Z-2285-2015	ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.	115 tools.	Class II	Terminated	5 Aug 2015
Z-2286-2015	ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.	110 tools.	Class II	Terminated	5 Aug 2015
Z-2287-2015	ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.	110 tools.	Class II	Terminated	5 Aug 2015
Z-2288-2015	ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.	91 tools.	Class II	Terminated	5 Aug 2015
Z-2289-2015	ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.	72 tools.	Class II	Terminated	5 Aug 2015
Z-2290-2015	ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.	353 tools.	Class II	Terminated	5 Aug 2015
Z-2291-2015	ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone including spine and cranium.	69 tools.	Class II	Terminated	5 Aug 2015
Z-2292-2015	ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.	142 tools.	Class II	Terminated	5 Aug 2015
Z-2293-2015	ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone including spine and cranium.	178	Class II	Terminated	5 Aug 2015
Z-2294-2015	ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium.	92 tools.	Class II	Terminated	5 Aug 2015
Z-2295-2015	ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium.	79 tools.	Class II	Terminated	5 Aug 2015
Z-2296-2015	ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.	103 tools.	Class II	Terminated	5 Aug 2015
Z-2297-2015	ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including spine and cranium.	95 tools.	Class II	Terminated	5 Aug 2015
Z-2298-2015	ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.	70 tools.	Class II	Terminated	5 Aug 2015
Z-2299-2015	ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium.	189 tools.	Class II	Terminated	5 Aug 2015
Z-2300-2015	ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine and cranium.	75 tools.	Class II	Terminated	5 Aug 2015
Z-2301-2015	ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine and cranium.	95 tools.	Class II	Terminated	5 Aug 2015
Z-2302-2015	ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.	88 tools.	Class II	Terminated	5 Aug 2015
Z-2303-2015	ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including spine and cranium.	118 tools.	Class II	Terminated	5 Aug 2015
Z-2304-2015	ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.	78 tools.	Class II	Terminated	5 Aug 2015
Z-2305-2015	ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.	70 tools.	Class II	Terminated	5 Aug 2015
Z-2306-2015	ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.	796 tools.	Class II	Terminated	5 Aug 2015
Z-2307-2015	ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.	99 tools.	Class II	Terminated	5 Aug 2015
Z-2308-2015	ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.	246	Class II	Terminated	5 Aug 2015
Z-2309-2015	ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium.	178 tools.	Class II	Terminated	5 Aug 2015
Z-2310-2015	ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.	70 tools.	Class II	Terminated	5 Aug 2015
Z-2311-2015	ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium.	80 tools.	Class II	Terminated	5 Aug 2015
Z-2312-2015	ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.	78 tools.	Class II	Terminated	5 Aug 2015
Z-2313-2015	ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.	686 tools.	Class II	Terminated	5 Aug 2015

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 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 34Median 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
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

The Anspach Effort, Inc.: all 35 events

Official channels

FDA enforcement report Z-2280-2015The 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 71212. https://recallregister.com/fda/ii/71212/. 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 including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
What quantity of product is in FDA event 71212?: The event has 34 product records. The first record gives this quantity: 65 tools.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.