Manufacturer

The Anspach Effort, Inc.

261 recalls in our database name The Anspach Effort, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 261
Critical: 1
Severe: 4
Most recent: 2023-01-18

Of the 261 recalls from The Anspach Effort, Inc. we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

251–261 of 261

ModerateFDA (Devices)·Z-0199-2014·2013-11-20
Anspach Effort Recalls Cutting Bur Chart Due to Labeling Error
Anspach Effort, Inc. is correcting labeling on its Cutting Bur Chart and related manuals because a claim about cutting biometals was not part of the device's intended use.
Product
Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0198-2014·2013-11-20
Anspach Effort Pneumatic Systems Operating Manual Labeling Correction
Anspach Effort is correcting labeling on Pneumatic Systems Operating Manuals to remove unverified claims about cutting biometals, bioplastics, and cement.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1658-2013·2013-07-10
Anspach Effort eMax 2 Plus Console Recalled for Low RPM
The Anspach Effort, Inc. is recalling eMax 2 Plus dental consoles because the motor handpiece may run at lower than expected speeds in free-running mode.
Product
***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** 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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1659-2013·2013-07-10
Anspach Effort eMax 2 Plus Console Recalled for Low RPM
The Anspach Effort, Inc. is recalling eMax 2 Plus Consoles because the motor handpiece may operate at lower speeds than specified.
Product
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1657-2013·2013-07-10
Anspach Effort eMax 2 Plus Console Recalled for Low Motor RPM
The Anspach Effort, Inc. is recalling eMax 2 Plus dental consoles because the motor handpiece may operate at lower than expected speeds in free-running conditions.
Product
***REF SC2100***eMax 2 Plus Console***SN 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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1377-2013·2013-06-05
Anspach Effort 3mm Diamond Ball Burrs Recalled for Grit Size Defect
The Anspach Effort, Inc. is recalling 1,827 3mm Diamond Ball burrs because three batches may have diamond grit larger than intended.
Product
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0783-2013·2013-02-13
Anspach Effort Recalls Bearing Sleeve Devices Due to Metal Fragment Risk
The Anspach Effort, Inc. is recalling 8 MA-15C Bearing Sleeve devices distributed in Massachusetts. The recall addresses a risk of metal fragments remaining in the surgical site.
Product
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.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0074-2013·2012-10-24
Anspach Effort Recalls Electric Systems Foot Control Due to Cable Defect
The Anspach Effort, Inc. is recalling 16 Electric Systems Foot Controls because the foot control cable lacks a shield connection. The defect could affect the device's performance during surgical procedures.
Product
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0076-2013·2012-10-24
Anspach Effort Recalls Electric Foot Controls Due to Cable Shield Defect
The Anspach Effort, Inc. is recalling 10 electric foot controls used for bone cutting because the cable lacks a shield connection.
Product
"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0075-2013·2012-10-24
Anspach Effort Recalls Electric Systems Foot Control Due to Cable Defect
The Anspach Effort, Inc. is recalling 41 Electric Systems Foot Controls because the foot control cable lacks a shield connection.
Product
"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2077-2012·2012-08-01
Anspach Effort Recalls Sterile Bone Cutting Burrs Due to Breakage Risk
The Anspach Effort, Inc. is recalling specific sterile bone cutting burrs because the cutter may come apart during use.
Product
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 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.
Category
Medical Device
Distribution
Distributed nationwide