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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach G1 Dissection Tool

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  Class 2 Device Recall Anspach G1 Dissection Tool see related information
Date Initiated by Firm April 13, 2015
Date Posted July 29, 2015
Recall Status1 Terminated 3 on August 25, 2016
Recall Number Z-2295-2015
Recall Event ID 71212
510(K)Number K113476  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1.
Cutting shaping bone including spine and cranium.
Code Information REF M-5B-2-G1 ; ALL lot numbers
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Medical Device Recall (Correction) of An
561-627-1080
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action Anspach sent an Urgent Notice: Medical Device Recall (Correction) letter of Anspach G1 Dissection Tools dated May 6, 2015, to all affected customers. Customers were not required to return their inventory of GI Dissection tools. Customers were instructed to complete, sign, and return the attached reply form confirming receipt of the letter by fax or email. Customers were also instructed to forward the letter as appropriate immediately. Customers with questions should contact the Complaint Handling Unit Manager at 561-494-3673 or contact their Anspach Sales Representative. For questions regarding this recall call 561-627-1080.
Quantity in Commerce 79 tools.
Distribution Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
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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