PlainRecalls

The Anspach Effort, Inc.

183 recalls on record · Latest: Jan 18, 2023

FDA Devices Moderate May 21, 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 …

FDA Devices Moderate Feb 5, 2014

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.

FDA Devices Moderate Feb 5, 2014

Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

FDA Devices Moderate Jan 22, 2014

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-…

FDA Devices Moderate Jan 22, 2014

MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily …

FDA Devices Moderate Jan 22, 2014

MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily…

FDA Devices Moderate Jan 22, 2014

MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in…

FDA Devices Moderate Jan 22, 2014

Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

FDA Devices Moderate Jan 22, 2014

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…

FDA Devices Moderate Jan 22, 2014

MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily…

FDA Devices Moderate Jan 22, 2014

MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily …

FDA Devices Moderate Jan 22, 2014

MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily…

FDA Devices Moderate Jan 22, 2014

MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in …

FDA Devices Moderate Jan 22, 2014

Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures

FDA Devices Moderate Jan 22, 2014

Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bon…

FDA Devices Moderate Jan 22, 2014

MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily…

FDA Devices Moderate Jan 22, 2014

MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in…

FDA Devices Moderate Jan 22, 2014

MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily…

FDA Devices Moderate Jan 22, 2014

MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily…

FDA Devices Moderate Jan 15, 2014

***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bon…

FDA Devices Moderate Jan 15, 2014

Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.

FDA Devices Moderate Jan 15, 2014

Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.

FDA Devices Moderate Jan 15, 2014

***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

FDA Devices Moderate Jan 15, 2014

***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.

FDA Devices Moderate Nov 20, 2013

Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, E…

FDA Devices Moderate Nov 20, 2013

Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems,…

FDA Devices Moderate Nov 20, 2013

Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Syste…

FDA Devices Moderate Jul 10, 2013

***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximatel…

FDA Devices Moderate Jun 5, 2013

***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.

FDA Devices Moderate Feb 13, 2013

Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphen…

FDA Devices Moderate Oct 24, 2012

"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.

FDA Devices Moderate Oct 24, 2012

"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spin…

FDA Devices Moderate Aug 1, 2012

.***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…