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The Anspach Effort, Inc.

190 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone recall (Z-0830-2014)The Anspach Effort, Inc.2014-01-27
Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intende recall (Z-0779-2014)The Anspach Effort, Inc.2014-01-16
Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. recall (Z-0749-2014)The Anspach Effort, Inc.2014-01-15
MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use recall (Z-0750-2014)The Anspach Effort, Inc.2014-01-15
MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use i recall (Z-0751-2014)The Anspach Effort, Inc.2014-01-15
MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use i recall (Z-0752-2014)The Anspach Effort, Inc.2014-01-15
MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use i recall (Z-0753-2014)The Anspach Effort, Inc.2014-01-15
MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in recall (Z-0754-2014)The Anspach Effort, Inc.2014-01-15
MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use i recall (Z-0755-2014)The Anspach Effort, Inc.2014-01-15
MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cu recall (Z-0756-2014)The Anspach Effort, Inc.2014-01-15
MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in c recall (Z-0757-2014)The Anspach Effort, Inc.2014-01-15
MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cu recall (Z-0758-2014)The Anspach Effort, Inc.2014-01-15
MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in c recall (Z-0759-2014)The Anspach Effort, Inc.2014-01-15
MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0760-2014)The Anspach Effort, Inc.2014-01-15
MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0761-2014)The Anspach Effort, Inc.2014-01-15
MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0762-2014)The Anspach Effort, Inc.2014-01-15
MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0763-2014)The Anspach Effort, Inc.2014-01-15
MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in recall (Z-0764-2014)The Anspach Effort, Inc.2014-01-15
MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0765-2014)The Anspach Effort, Inc.2014-01-15
MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cu recall (Z-0766-2014)The Anspach Effort, Inc.2014-01-15
MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in c recall (Z-0767-2014)The Anspach Effort, Inc.2014-01-15
MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cu recall (Z-0768-2014)The Anspach Effort, Inc.2014-01-15
MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in c recall (Z-0769-2014)The Anspach Effort, Inc.2014-01-15
Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB recall (Z-0726-2014)The Anspach Effort, Inc.2014-01-13
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM recall (Z-0727-2014)The Anspach Effort, Inc.2014-01-13
Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15D recall (Z-0728-2014)The Anspach Effort, Inc.2014-01-13
Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and recall (Z-0729-2014)The Anspach Effort, Inc.2014-01-13
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only recall (Z-0718-2014)The Anspach Effort, Inc.2014-01-11
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, prim recall (Z-0715-2014)The Anspach Effort, Inc.2014-01-10
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Inten recall (Z-0654-2014)The Anspach Effort, Inc.2014-01-09
***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended f recall (Z-0655-2014)The Anspach Effort, Inc.2014-01-09
***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. In recall (Z-0656-2014)The Anspach Effort, Inc.2014-01-09
***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: Th recall (Z-0657-2014)The Anspach Effort, Inc.2014-01-09
Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters recall (Z-0708-2014)The Anspach Effort, Inc.2014-01-09
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping recall (Z-0631-2014)The Anspach Effort, Inc.2014-01-06
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and recall (Z-0632-2014)The Anspach Effort, Inc.2014-01-06
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Moto recall (Z-0198-2014)The Anspach Effort, Inc.2013-11-13
Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Sys recall (Z-0199-2014)The Anspach Effort, Inc.2013-11-13
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Syste recall (Z-0200-2014)The Anspach Effort, Inc.2013-11-13
***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Mo recall (Z-1657-2013)The Anspach Effort, Inc.2013-07-02
***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Pro recall (Z-1658-2013)The Anspach Effort, Inc.2013-07-02
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Produ recall (Z-1659-2013)The Anspach Effort, Inc.2013-07-02
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone. recall (Z-1377-2013)The Anspach Effort, Inc.2013-05-24
Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable d recall (Z-0783-2013)The Anspach Effort, Inc.2013-02-04
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone i recall (Z-0074-2013)The Anspach Effort, Inc.2012-10-18
"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting recall (Z-0075-2013)The Anspach Effort, Inc.2012-10-18
"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usag recall (Z-0076-2013)The Anspach Effort, Inc.2012-10-18
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. recall (Z-2077-2012)The Anspach Effort, Inc.2012-07-25
"***REF QD11-6B***6 mm Fluted Ball. Use with QD11 Attachments. ***ANSPACH***Sterile, Steri recall (Z-0090-2012)The Anspach Effort, Inc.2011-10-21
"***REF QD8-5B***5 mm Fluted Ball. Use with QD8 Attachments. ***ANSPACH***Sterile, Sterili recall (Z-0091-2012)The Anspach Effort, Inc.2011-10-21
"***REF BLU-5***5 mm Fluted Ball. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Ster recall (Z-0092-2012)The Anspach Effort, Inc.2011-10-21
"***REF BLU-39***5 mm Fluted Acorn. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, St recall (Z-0093-2012)The Anspach Effort, Inc.2011-10-21
"***REF BLU-LS9-5E***4.7 mm x 20 mm Fluted Drum, Side Cut Only. Use with B-BLUE-S Attachme recall (Z-0094-2012)The Anspach Effort, Inc.2011-10-21
"***REF GRE-1***1.85 mm x 16 mm Fluted Router. Use with B-GREEN Attachments.***ANSPACH***S recall (Z-0095-2012)The Anspach Effort, Inc.2011-10-21
"***REF LHD-6B-M***6 mm Fluted Ball. Use with LONG-HD Attachment. ***ANSPACH***Sterile, St recall (Z-0096-2012)The Anspach Effort, Inc.2011-10-21
'***REF SIL-3-10***1.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER Attachment.***AN recall (Z-0097-2012)The Anspach Effort, Inc.2011-10-21
"***REF TURQ-L5***5 mm Fluted Ball. Use with B-TURQ-L Attachment. ***ANSPACH***Sterile, St recall (Z-0098-2012)The Anspach Effort, Inc.2011-10-21
"***REF L-CRN***2.5 mm x 25.4 mm Fluted Router. Use with CRANI-L Attachments.***ANSPACH*** recall (Z-0099-2012)The Anspach Effort, Inc.2011-10-21
"***REF A-CRN***1.85 mm x 16 mm Fluted Router. Use with CRANI-A Attachments.***ANSPACH***S recall (Z-0100-2012)The Anspach Effort, Inc.2011-10-21
"***REF S-35DC***3.5 mm Coarse Diamond Ball, Extended Length. Use with SHORT Attachments.* recall (Z-0101-2012)The Anspach Effort, Inc.2011-10-21
"***REF S-6AC***6 mm Fluted Acorn. Use with SHORT Attachments. ***ANSPACH***Sterile, Steri recall (Z-0102-2012)The Anspach Effort, Inc.2011-10-21
Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use recall (Z-3202-2011)The Anspach Effort, Inc.2011-09-14
Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. U recall (Z-3203-2011)The Anspach Effort, Inc.2011-09-14
Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 recall (Z-3189-2011)The Anspach Effort, Inc.2011-09-13
Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm Flute recall (Z-3190-2011)The Anspach Effort, Inc.2011-09-13
Sterile Bone Cutting Burrs model QD8-4OVD labeled in part:***QD8-4OVD***QTY: 1***4 mm x 8 recall (Z-3191-2011)The Anspach Effort, Inc.2011-09-13
Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted B recall (Z-3192-2011)The Anspach Effort, Inc.2011-09-13
Sterile Bone Cutting Burrs model SIL-7-9 labeled in part:***SIL-7-9***QTY: 1***9 mm Fluted recall (Z-3193-2011)The Anspach Effort, Inc.2011-09-13
"***REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (M recall (Z-2903-2011)The Anspach Effort, Inc.2011-08-01
***REF MCA5-15SD, QTY: 1***1.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment ( recall (Z-2904-2011)The Anspach Effort, Inc.2011-08-01
***REF MCA5-1SB, QTY: 1***1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA) recall (Z-2905-2011)The Anspach Effort, Inc.2011-08-01
***REF MCA5-2SB, QTY: 1***2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA) recall (Z-2906-2011)The Anspach Effort, Inc.2011-08-01
***REF MCA5-1SD, QTY: 1***1 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA recall (Z-2907-2011)The Anspach Effort, Inc.2011-08-01
***REF MCA5-2SD, QTY: 1***2 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA recall (Z-2908-2011)The Anspach Effort, Inc.2011-08-01
***REF MCA5-05SD, QTY: 1***0.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment ( recall (Z-2909-2011)The Anspach Effort, Inc.2011-08-01
***REF MCA5-06SD, QTY: 1***0.6 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment ( recall (Z-2910-2011)The Anspach Effort, Inc.2011-08-01
***REF MCA5-07SD, QTY: 1***0.7 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment ( recall (Z-2911-2011)The Anspach Effort, Inc.2011-08-01
***REF MCA5-08SD, QTY: 1***0.8 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment ( recall (Z-2912-2011)The Anspach Effort, Inc.2011-08-01
**REF MCA5-1SB*** 1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA). ***ANS recall (Z-2034-2011)The Anspach Effort, Inc.2011-04-20
***REF MCA5-15SB ***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).*** recall (Z-2035-2011)The Anspach Effort, Inc.2011-04-20
***REF MCA5-2SB*** 2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***ANS recall (Z-2036-2011)The Anspach Effort, Inc.2011-04-20
***REF MCA7-15SB*** 1.5 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment.***ANSPAC recall (Z-2037-2011)The Anspach Effort, Inc.2011-04-20
***REF MCA7-1SB*** 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***ANS recall (Z-2038-2011)The Anspach Effort, Inc.2011-04-20
***REF MCA7-2SB***2 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***ANSP recall (Z-2039-2011)The Anspach Effort, Inc.2011-04-20
Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trep recall (Z-0083-2010)The Anspach Effort, Inc.2009-10-28
Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Acces recall (Z-1039-2008)The Anspach Effort, Inc.2008-02-13
Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Acces recall (Z-1040-2008)The Anspach Effort, Inc.2008-02-13
Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessori recall (Z-1041-2008)The Anspach Effort, Inc.2008-02-13
Anspach Single Use, Sterile Bone Cutting Burrs recall (Z-1008-2007)The Anspach Effort, Inc.2007-07-11
Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does recall (Z-1243-03)The Anspach Effort, Inc.2003-10-15
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