The Anspach Effort, Inc.

FDA recalling firm · 35 enforcement events · 261 product records · 2011–2022 · FL

The Anspach Effort, Inc. has 35 FDA enforcement events on this register (261 product records) between 2011 and 2022: 35 device; the busiest year was 2012 with 7.

3% of its events are Class I; the most common class is Class II (34). 2 events are listed as ongoing; the recalling firm's address is in FL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
7 Dec 2022	6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium	Device	Class II	9	Ongoing
29 Sep 2017	OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.	Device	Class II	1	Terminated
6 Oct 2016	14cm QD Angle Attachment Product Usage: Product attachment	Device	Class II	103	Terminated
26 Aug 2016	G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.	Device	Class II	4	Terminated
24 Jun 2016	Light Adaptor for Small Battery Drive and Small Battery Drive II.	Device	Class I	2	Terminated
15 Jun 2016	Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.	Device	Class II	1	Terminated
28 Mar 2016	ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.	Device	Class II	2	Terminated
15 Jan 2016	Universal Battery Charger II (UBC II)	Device	Class II	1	Terminated
25 Nov 2015	Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.	Device	Class II	1	Terminated
2 Nov 2015	Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.	Device	Class II	1	Terminated
1 Jul 2015	Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.	Device	Class II	1	Terminated
13 Apr 2015	ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.	Device	Class II	34	Terminated
24 Mar 2015	Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.	Device	Class II	1	Terminated
10 Dec 2014	16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1	Device	Class II	1	Terminated
14 Nov 2014	Synthes Small Electric Drive (SED)	Device	Class II	1	Ongoing
14 Aug 2014	Synthes Small Electric Drive (SED). For use in general traumatology.	Device	Class II	1	Terminated
8 May 2014	Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.	Device	Class II	1	Terminated
8 Jan 2014	ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.	Device	Class II	1	Terminated
17 Dec 2013	Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and…	Device	Class II	4	Terminated
3 Dec 2013	Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.	Device	Class II	1	Terminated
6 May 2013	Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.	Device	Class II	1	Terminated
25 Apr 2013	*REF BLACKMAX-NSwivel/Angle Motor AssemblyRx Only*The Anspach Effort, Inc. Intended for cutting and shaping bone.	Device	Class II	4	Terminated
28 Nov 2012	ANSPACH*Knotless Suture Anchor Deployment Tool, CustomRx Only** This device is intended to be used with Anspach Systems	Device	Class II	45	Terminated
26 Oct 2012	Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED…	Device	Class II	1	Terminated
5 Sep 2012	Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.	Device	Class II	1	Terminated
11 Jun 2012	Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.	Device	Class II	2	Terminated
29 Mar 2012	Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures	Device	Class II	1	Terminated
29 Mar 2012	Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.	Device	Class II	21	Terminated
9 Jan 2012	"*Electric Systems Foot ControlRx Only*" Product Usage: Cutting and shaping bone including bones of the spine and cranium.	Device	Class II	3	Terminated
19 Sep 2011	.*ANSPACHSterile. REF SHD-4820DSQTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment *RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.	Device	Class II	1	Terminated
9 Sep 2011	Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only	Device	Class II	1	Terminated
24 Jun 2011	*REF SC2100eMax 2 Plus ConsoleSN G 10307653002* Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control…	Device	Class II	3	Terminated
6 May 2011	Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.	Device	Class II	3	Terminated
31 Mar 2011	AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.	Device	Class II	2	Terminated
4 Mar 2011	*REF S-3D* 3mm Diamond Ball. Used for cutting and shaping bone.	Device	Class II	1	Terminated

By type and class

Device35

Class II34

Class I1

Class I: 3% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for The Anspach Effort, Inc. by year initiated.

Questions and answers

How many FDA recalls has The Anspach Effort, Inc. had?

35 enforcement events (261 product records) on this register, 2011–2022: 35 device.

Are any The Anspach Effort, Inc. recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are The Anspach Effort, Inc. recalls?

34 Class II, 1 Class I. 3% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.