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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach MIA 16

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  Class 2 Device Recall Anspach MIA 16 see related information
Date Initiated by Firm May 06, 2013
Date Posted January 16, 2014
Recall Status1 Terminated 3 on April 18, 2016
Recall Number Z-0779-2014
Recall Event ID 67179
510(K)Number K965080  K011444  
Product Classification Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Product 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.
Code Information ALL LOTS
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact
561-627-1080
Manufacturer Reason
for Recall		 Product did not reach expected sterility assurance level
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action The firm, Aspach, sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated May 13, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/ customers were instructed that Sterrad 100S system should not be used on the MIA 16 attachment (the information only applies to only Sterrad sterilization of this devices and not to any other attachments.), and complete and return the Return Receipt Requested Customer Reply form via fax to: 1-800-327-6661 or email: ProductSupportTeam@synthes.com. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Should you have any queries, please do not hesitated to contact Anspach Product Support at (800) 327-6887. Hours of Operation are 8:30am-5:30pm Eastern Standard Time or email: ProductSupportTeam@synthes.com.
Quantity in Commerce 183
Distribution Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.
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 = ERL and Original Applicant = THE ANSPACH EFFORT, INC.
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