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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach Cutters and Attachments

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  Class 2 Device Recall Anspach Cutters and Attachments see related information
Date Initiated by Firm October 26, 2012
Date Posted January 09, 2014
Recall Status1 Terminated 3 on June 23, 2014
Recall Number Z-0708-2014
Recall Event ID 67124
510(K)Number K042783  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product 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 BALL, 5.6CM,
MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM,
MCA5-1SB - lMM FLUTED BALL, 5.6CM,
MCA5-1SD - lMM DIAMOND BALL, 5.6CM,
MCA5-2SB - 2MM FLUTED BALL, 5.6CM,
MCA5-2SD - 2MM DIAMOND BALL, 5.6CM,
MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM,
MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM,
MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM,
MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM,
MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM,
MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM,
MCA7-1SB - lMM FLUTED BALL, 7.3CM,
MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM,
MCA7-2SB - 2MM FLUTED BALL, 7.3CM and
MCA7-2SD - 2MM DIAMOND BALL, 7.3CM.

The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.
Code Information All Lots for  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 BALL, 5.6CM,  MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM,  MCA5-1SB - lMM FLUTED BALL, 5.6CM,  MCA5-1SD - lMM DIAMOND BALL, 5.6CM,  MCA5-2SB - 2MM FLUTED BALL, 5.6CM,  MCA5-2SD - 2MM DIAMOND BALL, 5.6CM,  MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM,  MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM,  MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM,  MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM,  MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM,  MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM,  MCA7-1SB - lMM FLUTED BALL, 7.3CM,  MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM,  MCA7-2SB - 2MM FLUTED BALL, 7.3CM and  MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. 
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Customer Support
800-327-6887
Manufacturer Reason
for Recall		 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 in dense bone removal may result in cu
FDA Determined
Cause 2		 Labeling False and Misleading
Action Anspach sent an Urgent Medical Removal letter dated October 26, 2012, to all affected customers. The letter stated that they were initiating a Medical Device removal regarding the MCA Cutting Burrs. During a recent review of documentation it was determined that the current directions for use for the MCA cutting burrs (item 18-0079) and MCA Micro Curved Attachment (item 18-0060) did 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 in dense bone removal may result in cutter/ burr fracture. If a fracture occurs, contact Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. If the procedure was done successfully, no additional patient follow up is necessary. Customer Immediate Actions: 1. Please remove and return any MCA items from your inventory immediately. 2. Complete the attached reply form indicating your receipt of this letter. Return the completed form by fax or email to the number or email address provided on the form. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Customers with questions were instructed to contact Anspach Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. For questions regarding this recall call 1-800-327-6887.
Quantity in Commerce 6,824 imits (4,7324 in USA / 2,100 Foreign)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, Great Britain, France, Sweeden, Italy, Spain, Japan, South Africa, Australia, Switzerland,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HBE and Original Applicant = THE ANSPACH EFFORT, INC.
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