Data / Medical devices / United States / The Anspach Effort, Inc.
The Anspach Effort, Inc.: FDA-registered device maker in Palm Bch Gdns, FL, United States, 22 510(k) clearances
The Anspach Effort, Inc. is registered with the FDA (registration 1045834) in Palm Bch Gdns, FL, United States. It lists 19 device types. The FDA files 22 510(k) clearances under its listings, the newest dated June 14, 2024. 44 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1045834
- Address
- 4500 Riverside DR., Palm Bch Gdns, FL, United States, 33410
- Owner or operator
- THE ANSPACH EFFORT, INC. (1045834)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 15, 2003
- Registered through
- 2027
- Brand names listed
- Anspach Attachments, Anspach BlackMax Pneumatic Drill System, Anspach Compact SpeedReducer, Anspach Dissection Tools, Anspach Helix Dissection Tools, Anspach Irrigation System, Anspach MRI Safe Surgical Drill System, Anspach MicroMax System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Battery, Replacement, Rechargeable | MOQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bur, Ear, Nose And Throat | EQJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Complaint file establishment | accessdata.fda.gov |
| Drill, Bone, Powered | DZI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Driver, Wire, And Bone Drill, Manual | DZJ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Motor, Drill, Electric | HBC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Motor, Drill, Pneumatic | HBB | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Motor, Surgical Instrument, Ac-Powered | GEY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 14, 2024 | K233228 | Spine Navigation and Robotic-Assistance Device | OLO | Substantially Equivalent | Ecential Robotics | accessdata.fda.gov |
| June 5, 2024 | K240211 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 14, 2023 | K233227 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| May 19, 2022 | K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | HBC | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| January 14, 2021 | K202769 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 19, 2019 | K183545 | Anspach Helix Dissection Tools | HBE | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| March 27, 2018 | K180063 | OCM-G1 Attachment | ERL | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| January 10, 2014 | K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | HBC | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| December 31, 2013 | K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | ERL | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| December 16, 2011 | K113476 | ANSPACH DISSECTION TOOLS | HBE | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| April 14, 2010 | K093361 | SYNTHES AIR PEN DRIVE (APD) SYSTEM | HBB | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| April 30, 2009 | K082649 | SYNTHES 90 DEGREE SCREWDRIVER | DZI | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| April 30, 2008 | K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | HBE | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| January 16, 2007 | K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | HWE | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| January 5, 2005 | K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | HWE | Substantially Equivalent | Synthes (Usa) | accessdata.fda.gov |
| December 17, 2004 | K042783 | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM | HBE | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| March 15, 2004 | K040076 | ANSPACH ADVANCED MICRO SAW ATTACHMENTS | HBE | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| August 8, 2001 | K011444 | ANSPACH EMAX DRILL SYSTEM | HBC | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| July 6, 1998 | K974025 | ANSPACH SHIELDED ATTACHMENT | GFF | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| January 10, 1997 | K965080 | ANSPACH MICROMAX SYSTEM | ERL | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| November 19, 1996 | K960630 | ANSPAHC SPEED REDUCER | HBB | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
| January 17, 1996 | K955084 | ASPACH 65,000 (MODIFICATION) | HSZ | Substantially Equivalent | The Anspach Effort, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 7, 2022 | 91231 | Class II | Ongoing | 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 | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | accessdata.fda.gov |
| September 29, 2017 | 78901 | Class II | Terminated | 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. | This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account. | accessdata.fda.gov |
| October 6, 2016 | 76059 | Class II | Terminated | 14cm QD Angle Attachment Product Usage: Product attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | accessdata.fda.gov |
| August 26, 2016 | 75121 | Class II | Terminated | G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium. | Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed. | accessdata.fda.gov |
| June 24, 2016 | 74835 | Class I | Terminated | Light Adaptor for Small Battery Drive and Small Battery Drive II. | There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. | accessdata.fda.gov |
| June 15, 2016 | 74447 | Class II | Terminated | Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine. | The graphics at the attachment interface indicating locked and unlocked position are reversed. | accessdata.fda.gov |
| March 28, 2016 | 73738 | Class II | Terminated | 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 otolo | Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size. | accessdata.fda.gov |
| January 15, 2016 | 73203 | Class II | Terminated | Universal Battery Charger II (UBC II) | The device is reported to enter safe mode and is no longer able to charge batteries. | accessdata.fda.gov |
| November 25, 2015 | 73198 | Class II | Terminated | Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc. | Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON". | accessdata.fda.gov |
| November 2, 2015 | 73197 | Class II | Terminated | Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures. | Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498). | accessdata.fda.gov |
| July 1, 2015 | 71659 | Class II | Terminated | Synthes Battery Power Line II Oscillator Model, orthopedic surgical power tool. | Saw head separated from the drive unit or began to come loose. | accessdata.fda.gov |
| April 13, 2015 | 71212 | Class II | Terminated | ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM, REF L-10DRC-G1 Cutting shaping bone including spine and cranium. | 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. | accessdata.fda.gov |
| March 24, 2015 | 70919 | Class II | Terminated | Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: for orthopedic surgery. | The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user. | accessdata.fda.gov |
| December 10, 2014 | 70184 | Class II | Terminated | 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1 | Customer complaint indicating the color bands on the MIA16-G1 were not correct. | accessdata.fda.gov |
| November 14, 2014 | 69974 | Class II | Ongoing | Synthes Small Electric Drive (SED) | May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start. | accessdata.fda.gov |
| August 14, 2014 | 73000 | Class II | Terminated | Synthes Small Electric Drive (SED). For use in general traumatology. | The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. | accessdata.fda.gov |
| May 8, 2014 | 68496 | Class II | Terminated | Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium. | Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device. | accessdata.fda.gov |
| January 8, 2014 | 68109 | Class II | Terminated | 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. | Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product. | accessdata.fda.gov |
| December 17, 2013 | 67146 | Class II | Terminated | 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 Carbid | Some carbide cutting burr fractured during use. | accessdata.fda.gov |
| December 3, 2013 | 68021 | Class II | Terminated | 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. | The Irrigation Clips were assembled with the incorrect (smaller) clips. | accessdata.fda.gov |
| May 6, 2013 | 67179 | Class II | Terminated | 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. | Product did not reach expected sterility assurance level | accessdata.fda.gov |
| April 25, 2013 | 66323 | Class II | Terminated | REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone. | The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use.. | accessdata.fda.gov |
| November 28, 2012 | 64247 | Class II | Terminated | ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements. | accessdata.fda.gov |
| October 26, 2012 | 67124 | Class II | Terminated | 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 | During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device | accessdata.fda.gov |
| September 5, 2012 | 63793 | Class II | Terminated | 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. | Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur | accessdata.fda.gov |
| June 11, 2012 | 67131 | Class II | Terminated | Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone. | Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD). | accessdata.fda.gov |
| March 29, 2012 | 67177 | Class II | Terminated | Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures | Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs. | accessdata.fda.gov |
| March 29, 2012 | 63624 | Class II | Terminated | 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 cochleost | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling c | accessdata.fda.gov |
| January 9, 2012 | 63086 | Class II | Terminated | "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body. | accessdata.fda.gov |
| September 19, 2011 | 62326 | Class II | Terminated | .***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. | Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart. | accessdata.fda.gov |
| September 9, 2011 | 63071 | Class II | Terminated | Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only | Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier. | accessdata.fda.gov |
| June 24, 2011 | 64973 | Class II | Terminated | 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 RPM of the Motor Handpiece may be less than 80,000 RPM. | accessdata.fda.gov |
| May 9, 2011 | 58985 | Not yet classified | Terminated | Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufact | The Anspach Effort, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #'s C323023789, C403026551, C473028567, C403026563, D153034013, D173034385, and C363024789, because the bar code which defines the expiration date may be incorrect. This c | accessdata.fda.gov |
| May 6, 2011 | 65863 | Class II | Terminated | 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: | Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has | accessdata.fda.gov |
| March 31, 2011 | 67176 | Class II | Terminated | 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. | Cutter was longer than was stated on the label | accessdata.fda.gov |
| March 17, 2011 | 59182 | Not yet classified | Terminated | Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Drive***Palm Beach Garden | The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr being 2.0 mm longer than stated on the label. As a result, a hole drilled using this burr would be 2 mm deeper than the s | accessdata.fda.gov |
| March 4, 2011 | 64886 | Class II | Terminated | REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone. | Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr. | accessdata.fda.gov |
| October 13, 2010 | 58698 | Not yet classified | Terminated | "***REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacture The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Garde | On July 30th, 2010 the Anspach Effort, Inc. initiated a voluntary recall on their Anspach Single Use, Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. | accessdata.fda.gov |
| September 29, 2010 | 57933 | Not yet classified | Terminated | REF MCA5-1SB*** 1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA). ***ANSPACH***Sterile. Sterilized using Irradiation***Rx Only.***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Dr | Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. Anspach has not received any complaints related to this problem. | accessdata.fda.gov |
| August 13, 2009 | 53073 | Not yet classified | Terminated | Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP. Indicated to cut and shape bone including bones of the spine | The Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions which could possibly cause interference on other electrical | accessdata.fda.gov |
| May 19, 2008 | 59837 | Not yet classified | Terminated | "***REF QD11-6B***6 mm Fluted Ball. Use with QD11 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gard | The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008. | accessdata.fda.gov |
| May 18, 2007 | 37977 | Not yet classified | Terminated | Anspach Single Use, Sterile Bone Cutting Burrs | The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product. | accessdata.fda.gov |
| December 18, 2006 | 37183 | Not yet classified | Terminated | Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410. | Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can withstand ETO sterilization, but there is no data to support this process. | accessdata.fda.gov |
| April 23, 2003 | 26308 | Not yet classified | Terminated | Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs) | Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart. | accessdata.fda.gov |
Compare with other makers
- All makers of Drills, Burrs, Trephines & Accessories (Simple, Powered)
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- All makers of Bur, Surgical, General & Plastic Surgery
- All makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- All makers of Drill, Bone, Powered
Updated June 14, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.